[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NRG Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":665},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,48,70,107,131,155,179,203,263,286,310,333,356,378,401,423,451,483,504,527,545,567,590,611,635],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100573587","phase-3-e-mindfulness-approaches-for-living-after-breast-cancer-100573587",false,"NCT06748222","E-Mindfulness Approaches for Living After Breast Cancer","Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC","HEAL-ABC","Inclusion Criteria:\n\n* The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.\n* The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.\n* The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.\n* The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).\n* Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4\u002F6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)\n* Participant must be able to understand, speak, read, and write in English or Spanish.\n* Participant must be willing to participate in a 6-week program to receive training in mindfulness.\n* Participant must be able to use a smartphone, tablet, or other digital device.\n* Sex assigned at birth must be female.\n\nExclusion Criteria:\n\n* Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .\n* Any history or current evidence of recurrent or metastatic breast cancer.\n* Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.\n* Currently pregnant or planning to become pregnant in the near future.\n* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.","ALL","18 Years","50 Years",{"count":22,"type":23},402,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and\u002For chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.",[29,30],"Breast Cancer","Depression",[29,32,33,34],"Mindfulness","Meditation","Digital","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2025-06-27",{"date":43,"type":23},"2030-02-28",{"name":45,"class":46},"NRG Oncology","OTHER",364,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100506864","phase-3-evaluating-the-addition-of-adjuvant-chemotherapy-to-ovarian-function-suppression-plus-endocrine-therapy-in-premenopausal-patients-with-pn0-1-er-positiveher2-negative-breast-cancer-and-an-oncotype-recurrence-score-less-than-or-equal-to-25-100506864","NCT05879926","Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive\u002FHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25","A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive\u002FHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)","OFSET","Inclusion Criteria:\n\n* A patient cannot be considered eligible for this study unless ALL of the following conditions are met.\n\n  * The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.\n  * Female patients must be greater than or equal to 18 years of age.\n  * Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:\n  * Age 50 years or under with spontaneous menses within 12 months; or\n  * Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or\n  * Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or\n  * Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.\n  * The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%).\n  * Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n  * Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n  * Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.\n  * For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.)\n  * For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.)\n  * Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).\n  * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:\n  * By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.)\n  * By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c).\n  * Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes.\n  * Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1.\n  * Oncotype DX RS (recurrence score) requirements\\*:\n  * If node-negative:\n  * Oncotype DX RS must be RS 21-25, or\n  * Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm.\n  * If 1-3 nodes involved:\n  * Oncotype DX RS must be less than 26.\n\n    \\* Patients with a \"Low Risk\" or \"MP1\" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible.\n  * The tumor must be ER and\u002For PgR-positive (progesterone receptor) by current ASCO\u002FCAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and\u002For PgR staining by IHC will be classified as positive.\n  * The tumor must be HER2-negative by current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines based on local testing results.\n  * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.\n  * Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.\n  * Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.\n\nExclusion Criteria:\n\n* • Definitive clinical or radiologic evidence of metastatic disease.\n\n  * pT4 (pathological state) tumors, including inflammatory breast cancer.\n  * History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and\u002For previous DCIS or LCIS are eligible.)\n  * If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.\n  * Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.\n\nKnown results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:\n\n* ANC (absolute neutrophil count) less than 1200\u002Fmm3;\n* Platelet count less than 100,000\u002Fmm3;\n* Hemoglobin less than 10 g\u002FdL;\n* Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;\n* AST(aspartate aminotransferase)(SGOT)\u002FALT (alanine transminase)(SGPT): greater than 3 × institutional ULN;\n* Renal function of GFR (glomular filtration rate) less than 30 mL\u002Fmin\u002F1.73m2.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Non-epithelial breast malignancies such as sarcoma or lymphoma.\n* Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.\n* Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin\u002Fprogesterone IUDs).\n* Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy.\n* Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.)\n* Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.","FEMALE","60 Years",{"count":59,"type":23},3960,[26],"This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).",[29],{"date":38,"type":39},{"date":65,"type":39},"2023-10-18",{"date":67,"type":23},"2034-07",{"name":45,"class":46},1249,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":24,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100452642","phase-2-colon-adjuvant-chemotherapy-based-on-evaluation-of-residual-disease-100452642","NCT05174169","Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease","CIRCULATE-US","Inclusion Criteria:\n\nThe patient must have an ECOG performance status of 0 or 1.\n\nPatients must have histologically\u002Fpathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.\n\nNo radiographic evidence of overt metastatic disease within 45 days prior to Step 1\u002FStudy entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).\n\nThe distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).\n\nThe patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.\n\nThe resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1\u002FStudy entry and before Step2\u002FRandomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery).\n\nTumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.\n\nThe treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).\n\nThe interval between surgery (post-operative Day 7) and Step 1\u002FStudy entry must be no more than 60 days. NOTE: Step 1\u002FStudy Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery.\n\nAvailability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.\n\nAdequate hematologic function within 28 days before Step 1\u002FStudy entry defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500\u002Fmm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000\u002Fmm3; and\n* Hemoglobin must be greater than or equal to 9 g\u002FdL.\n\nAdequate hepatic function within 28 days before Step 1\u002FStudy entry defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before Step 1\u002FStudy entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg\u002FdL) For Men Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) 72 x serum creatinine (mg\u002FdL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW).\n\nHIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1\u002FStudy entry must be negative (for women of childbearing potential only).\n\nPatients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.\n\nEligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPatient must have developed a ctDNA +ve assay during serial monitoring.\n\nPatient's willingness to be re-randomized affirmed.\n\nThe patient must continue to have an ECOG performance status of 0 or 1.\n\nNo radiographic evidence of overt metastatic disease.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).\n\nAdequate hematologic function within 28 days before second randomization defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500\u002Fmm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000\u002Fmm3; and\n* Hemoglobin must be greater than or equal to 9 g\u002FdL.\n\nAdequate hepatic function within 28 days before second randomization defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg\u002FdL) For Men Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) 72 x serum creatinine (mg\u002FdL)\n\nExclusion Criteria:\n\nColon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).\n\nPathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.\n\nTumor-related bowel perforation.\n\nHistory of prior invasive colon malignancy, regardless of disease-free interval.\n\nHistory of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ\u002Ftissue donation are not exclusionary.\n\nAny prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and\u002For radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization.\n\nOther invasive malignancy within 5 years before Step 1\u002FStudy entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.\n\nSynchronous primary rectal and\u002F or colon cancers.\n\nPatients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\nSensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0.\n\nBlood transfusion within two weeks before collection of blood for central ctDNA testing.\n\nActive seizure disorder uncontrolled by medication.\n\nActive or chronic infection requiring systemic therapy.\n\nKnown homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.\n\nPatients known to have Gilbert's Syndrome or homozygosity for UGT1A1\\*28 polymorphism.\n\nPregnancy or lactation at the time of Step 1\u002FStudy entry.\n\nCo-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).\n\nIneligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPregnancy or lactation at the time of randomization.\n\nNo longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.",{"count":78,"type":23},1912,[80,26],"PHASE2","This Phase II\u002FIII trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.",[83],"Stage III Colon Cancer",[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"ctDNA positive","ctDNA negative","Adjuvant Chemotherapy","Natera","Signatera","mFOLFOX6","Stage III","CAPOX","mFOLFIRINOX","Oxaliplatin","5-Fluorouracil (5-FU)","Capecitabine","Leucovorin","Irinotecan","Stage II",{"date":38,"type":39},{"date":102,"type":39},"2022-07-08",{"date":104,"type":23},"2030-03-10",{"name":45,"class":46},1063,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100445456","five-or-ten-year-colonoscopy-for-1-2-non-advanced-adenomatous-polyps-100445456","NCT05080673","Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps","FORTE","Inclusion Criteria:\n\n* The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.\n* Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy.\n* Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization.\n* Sessile serrated polyps\u002Fadenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.\n* Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.\n* Complete excision of all observed polyps in qualifying colonoscopy\n* Participants must be able to read or understand English or Spanish.\n\nExclusion Criteria:\n\n* • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps\u002Fadenomas excluding those found on the qualifying colonoscopy.\n\n  * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.\n  * Traditional serrated adenomas found on the qualifying colonoscopy.\n  * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.\n  * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.\n  * Colonoscopy performed after the qualifying colonoscopy but prior to randomization.\n  * Incomplete qualifying colonoscopy (e.g., cecum not visualized).\n  * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)\n  * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)\n  * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.\n  * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \\[Lynch Syndrome\\]).\n  * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \\[Lynch Syndrome\\] genetic mutation that increases risk of colorectal cancer.\n  * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).\n  * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.\n  * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.","45 Years","70 Years",{"count":117,"type":23},9500,[119],"NA","This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.",[122,123],"Adenocarcinoma of the Colon","Adenocarcinoma of the Rectum",{"date":38,"type":39},{"date":126,"type":39},"2022-02-09",{"date":128,"type":23},"2065-11-01",{"name":45,"class":46},485,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":24,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100424265","phase-3-testing-if-high-dose-radiation-only-to-the-sites-of-brain-cancer-compared-to-whole-brain-radiation-that-avoids-the-hippocampus-is-better-at-preventing-loss-of-memory-and-thinking-ability-100424265","NCT04804644","Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability","Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);\n\n  * Patients with de novo or recurrent small cell lung cancer are permitted.\n* Brain metastases =\\\u003C 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\\\u003C 21 days prior to study entry.\n\n  * The total tumor volume must be 30 cm\\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz\u002F2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.\n  * Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.\n  * Brain metastases must be diagnosed on MRI, which will include the following elements:\n\n    * REQUIRED MRI ELEMENTS\n\n      * Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.\n      * Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).\n      * A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.\n    * ADDITIONAL RECOMMENDATIONS\n\n      * Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.\n      * Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.\n      * Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.\n      * Recommendation is that the study participants be scanned on the same MRI instrument at each time point.\n      * Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.\n      * If additional sequences are obtained, total imaging time should not exceed 60 minutes.\n      * If additional metastases not known at the time of registration\u002Frandomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\\^3, the patient is still considered eligible.\n* History\u002Fphysical examination\n* Age \\>= 18\n* Karnofsky performance status of \\>= 70\n* Creatinine clearance \\>= 30 ml\u002Fmin\n* Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and\u002For immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-\u002Fpost-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility.\n\n  * Patients with symptomatic brain metastases and\u002For brain metastases in eloquent locations (e.g., brainstem, pre-\u002Fpost central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients.\n* Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.\n* Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.\n* Patients may have had prior intracranial surgical resection.\n* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.\n* The patient must provide study-specific informed consent prior to study entry.\n\n  * Patients with impaired decision-making capacity are not permitted on study.\n* ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION\n* The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.\n\n  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n* PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.\n\nNOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n\nExclusion Criteria:\n\n* Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.\n\n  * For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.\n* Brainstem metastasis \\> 10 cm\\^3\n* Prior allergic reaction to memantine.\n* Patients with definitive leptomeningeal metastases.\n* Known history of demyelinating disease such as multiple sclerosis.\n* Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI).\n* Current use of (other N-methyl-D-aspartate \\[NMDA\\] antagonists) amantadine, ketamine, or dextromethorphan.\n* Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt.\n\n  * Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.\n* Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).",{"count":139,"type":23},200,[26],"This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.",[143,144,145,146],"Metastatic Lung Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Brain","Recurrent Lung Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8","2026-06-30",{"date":36,"type":39},{"date":150,"type":39},"2021-06-08",{"date":152,"type":23},"2030-07-01",{"name":45,"class":46},231,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":24,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100605737","phase-3-testing-immunotherapy-with-or-without-stereotactic-body-radiation-therapy-in-patients-with-advanced-liver-cancer-helio-rt-trial-100605737","NCT07166406","Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial","Phase III Randomized Trial of IO-Based Systemic Treatment +\u002F- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* Diagnosis of hepatocellular carcinoma (HCC) by at least 1 criterion listed below:\n\n  * Pathologically (histologically or cytologically) proven diagnosis of HCC (strongly recommended)\n  * Radiographically proven (American Association for the Study of Liver Diseases \\[AASLD\\] criteria) diagnosis of HCC by multiphasic MRI and\u002For CT scan is allowed.\n  * For patients with a prior or concurrent malignancy, pathologic confirmation of hepatocellular cancer is required.\n* HCC macrovascular invasion, defined as enhancing vascular thrombosis demonstrating arterial enhancement and venous or delayed venous washout on multiphasic MRI and\u002For CT is required.\n* Presence of extrahepatic metastatic disease on CT chest and CT or MRI pelvis, or PET\u002FCT chest\u002Fabdomen\u002Fpelvis is permitted.\n* 5 or fewer discrete intrahepatic parenchymal foci of HCC.\n* Total maximal sum of hepatocellular carcinoma tumors, as a single conglomerate, multiple lesions, or infiltrative HCC \\\u003C 20 cm in total summed diameter.\n* No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.\n* No known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.\n* Child-Pugh class A or B7 liver function.\n* Age ≥ 18.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3.\n* Platelets ≥ 60,000 cells\u002Fmm\\^3.\n* Hemoglobin ≥ 8g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8g\u002Fdl is acceptable).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 6 x institutional upper limit of normal (ULN).\n* Total bilirubin \\\u003C 4 x institutional ULN.\n* Creatinine clearance (CrCL) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 by the Cockcroft-Gault formula.\n* For treatment of HCC:\n\n  * Prior surgical resection, transarterial chemoembolization (TACE), and ablation are permitted.\n  * No prior systemic therapy or transarterial radioembolization (TARE) for HCC.\n  * No history of liver transplantation.\n* For prior treatment for any malignancy:\n\n  * Prior systemic therapy for a different cancer is allowable, except for prior immunotherapy.\n  * No prior radiotherapy to the region of the study cancer that would result in significant overlap of radiation therapy fields that would lead to excessive cumulative toxicity at the discretion of the investigator.\n* No medical contraindication to the standard of care immunotherapy.\n* For patients to be treated with atezolizumab\u002Fbevacizumab:\n\n  * No history of a gastrointestinal (GI) bleed or other clinically significant bleeding event within 6 months prior to study registration.\n* Systemic immunostimulatory agents (including, but not limited to, interferons and interleukin-2 \\[IL-2\\]) are prohibited within 4 weeks or five drug elimination half-lives (whichever is longer) prior to registration and during the study period.\n* No history of allergic reaction to the systemic therapy agent(s), compounds of similar chemical or biologic composition to the systemic therapy agent(s) (or any of its excipients).\n* PRIOR TO STEP 2 RANDOMIZATION:\n* Obtain confirmation of payment coverage (insurance or other) for both possible treatment arms.",{"count":163,"type":23},226,[26],"This phase III trial compares the effect of immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. IO with monoclonal antibodies, such as durvalumab, tremelimumab, atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.",[167,168,169],"Advanced Hepatocellular Carcinoma","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","2026-06-22",{"date":172,"type":39},"2026-06-25",{"date":174,"type":39},"2026-02-26",{"date":176,"type":23},"2029-03-10",{"name":45,"class":46},139,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":24,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100589739","phase-3-testing-higher-dose-radiation-therapy-for-locally-advanced-pancreatic-cancer-100589739","NCT06958328","Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer","A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)","LAP100","Inclusion Criteria:\n\n* At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine\u002Fnab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. \"Active chemotherapy\" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle\n* BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n* Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma\n* Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \\[NCCN\\] guidelines and institutional tumor board review)\n* Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment\n* Age ≥ 18 years\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2\n* Required initial laboratory values:\n\nAll laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy\n\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)\n* BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria\n\n  * If baseline CA19-9 \\> 37 U\u002FmL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe \\[up to 30 days post chemotherapy initiation\\])\n  * If baseline CA19-9 U\u002FmL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value\n\n    * Prior radiation treatment\n* Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted\n* If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford\n\n  * POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n  * If baseline CA19-9 is elevated (defined as \\> 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u\u002FmL or a 50% decline from pre-chemotherapy level with absolute value less than 100u\u002FmL\n  * If baseline CA19-9 is not elevated (defined as ≤ 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u\u002FmL\n  * No active duodenal or gastric ulcers\n  * No direct tumor invasion of the bowel or stomach\n  * Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, or CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment, with restaging CT showing at least stable disease\n  * Not pregnant and not nursing\n  * No cardiac condition that was the primary reason for hospitalization in the last 6 months\n  * New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",{"count":188,"type":23},356,[26],"This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.",[192,193,194,195],"Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8",{"date":172,"type":39},{"date":198,"type":39},"2025-08-21",{"date":200,"type":23},"2030-10-21",{"name":45,"class":46},322,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100556989","phase-2-testing-the-addition-of-the-drug-bmx-001-a-radioprotector-or-a-placebo-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-100556989","NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.",{"count":211,"type":23},98,[80],"This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stomatitis",{"date":172,"type":39},{"date":258,"type":39},"2025-06-23",{"date":260,"type":23},"2027-01-01",{"name":45,"class":46},153,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":24,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100554545","phase-3-testing-proton-craniospinal-radiation-therapy-versus-the-usual-radiation-therapy-for-leptomeningeal-metastasis-radiate-lm-trial-100554545","NCT06500481","Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial","A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (Radiate-LM)","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION\n* Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC\n* Patients must have newly diagnosed leptomeningeal metastasis established through at least one of the following:\n\n  * Positive CSF cytology for malignancy\n\n    * CSF cytology with suspicious cells is considered positive; CSF cytology with atypical cells is considered equivocal and not positive\n  * Patients with an equivocal or negative CSF cytology result, or not suitable for CSF sampling, radiographic diagnosis of leptomeningeal metastasis with linear and\u002For nodular disease and documentation of typical clinical signs (European Association of Neuro-Oncology \\[EANO\\]-European Society for Medical Oncology \\[ESMO\\] Diagnostic Criteria Type IIA-IIC) is required\n\n    * Patients with typical clinical signs of leptomeningeal metastasis may have one or more of the following symptoms and signs: headache, nausea, vomiting, mental status change, gait difficulty, cranial nerve palsy, diplopia, visual change, hearing loss, radicular weakness, radicular sensory change, urinary retention, saddle anesthesia, constipation, neck pain, and back pain\n  * For patients with prior history of immunotherapy or current immunotherapy, CSF sampling rather than just MRI enhancement is strongly recommended to exclude immune-related aseptic meningitis\n* Patients must be candidates for radiation therapy for the treatment of leptomeningeal metastasis\n* Age ≥ 18\n* PRIOR TO STEP 2 REGISTRATION\n* Note: Step 2 registration must occur no later than 30 calendar days after step 1 registration\n* Financial clearance for proton therapy treatment\n* Patients must have systemic disease evaluation through standard of care imaging for example CT chest\u002Fabdomen\u002Fpelvis or body PET\u002FCT\n* Karnofsky performance status ≥ 60\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8.0 g\u002Fdl is acceptable)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (Note: the use of granulocyte-colony stimulating factor or other intervention to achieve ANC ≥ 1,000\u002Fmm\\^3 is acceptable)\n* Platelets ≥ 100,000\u002Fmm\\^3 (Note: the use of transfusion or other intervention to achieve platelets ≥ 100,000\u002Fmm\\^3 is acceptable)\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (patients with known Gilbert disease without other clinically significant liver abnormalities are not excluded)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × ULN\n* No prior radiation therapy to the spinal cord with equivalent dose in 2 gray (Gy) fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using alpha\u002Fbeta ratio of 3\n* No prior treatment for leptomeningeal metastasis (note: prior CNS treatment for other non-leptomeningeal disease is allowed)\n* No history of unstable angina requiring hospitalization in the last 3 months\n* No history of myocardial infarction within the last 3 months\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection currently requiring intravenous (IV) antibiotic management\n* No active chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy\n* No CTCAE v5.0 ≥ grade 2 encephalopathy",{"count":271,"type":23},115,[26],"This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and\u002For prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.",[275,276,277,278,146],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Leptomeninges",{"date":172,"type":39},{"date":281,"type":39},"2025-03-04",{"date":283,"type":23},"2028-07-31",{"name":45,"class":46},58,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":24,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100554543","phase-3-testing-longer-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-with-cancer-that-has-spread-to-the-brain-100554543","NCT06500455","Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain","Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:\n\n  * Non-small cell lung cancer\n  * Melanoma\n  * Breast cancer\n  * Renal cell carcinoma\n  * Gastrointestinal cancer\n  * If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest\u002Fabdomen\u002Fpelvis, positron emission tomography \\[PET\\]\u002FCT, etc.) is required\n* Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration\n* At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm\n* All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension\n\n  * Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS\u002FFSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator\n* Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5\n* No more than 2 lesions planned for resection if clinically indicated\n* No known leptomeningeal disease (LMD)\n\n  * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and\u002For unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion\n* Age ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 60\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \\[PCI\\])\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)\n* No active infection currently requiring intravenous (IV) antibiotic management\n* No hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy",{"count":294,"type":23},269,[26],"This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.",[275,276,298,277,144,299,300,301,146,302],"Metastatic Digestive System Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Stage IV Renal Cell Cancer AJCC v8",{"date":172,"type":39},{"date":305,"type":39},"2024-12-12",{"date":307,"type":23},"2028-06-30",{"name":45,"class":46},270,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":318,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":24,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100537529","comparing-telephone-symptom-monitoring-interventions-for-managing-symptoms-and-psychological-distress-during-oral-anti-cancer-treatment-100537529","NCT06279013","Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment","Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment","SYMON","Inclusion Criteria:\n\n* PRACTICES: All institutions participating in the practice are National Cancer Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates.\n* PRACTICES: Administer oral therapy to at least 40 patients per year that meet protocol eligibility criteria.\n* PRACTICES: Completion and submission of the NRG-CC012CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit \\[CTSU\\] website).\n* PRACTICES: Having a social worker licensed in behavioral counseling or other person eligible for behavioral licensing in the practice's state or territory (if licensure is required by state or territory) who can be trained to deliver TIPC or willingness of practice to work with TIPC intervener contracted by the study team. Note: If the practice's social worker or other behavioral health professional is trained to deliver TIPC, they will be compensated for their time training and delivering the TIPC intervention.\n* PRACTICE PERSONNEL: Age ≥ 18 years.\n* PRACTICE PERSONNEL: Planned to be involved in usual care for at least one enrolled patient during patient's participation in the study.\n* PRACTICE PERSONNEL: For a social worker or other behavioral health professional who will deliver TIPC intervention, licensure, or eligibility for licensure in behavioral counseling if required by the state or territory.\n* PRACTICE PERSONNEL: The practice personnel must provide study-specific informed consent prior to study entry.\n* RETAIN PRACTICE PARTICIPATION: In order to maintain participation in the study, practices must enroll at least 8 patients in the first 6 months (based upon the practice's monthly tracking reports) the practice is open to patient accrual to ensure that the practice can meet the accrual goals. If a practice does not meet this criterion they will be replaced.\n* RETAIN PRACTICE PARTICIPATION: Complete monthly forms on actions taken on IVR symptom reports. If fewer than 2 forms are completed in the first 6 months of practice's participation, practice will be replaced.\n* RETAIN PRACTICE PARTICIPATION: Participate in monthly study calls for the duration of practice's participation in the study.\n* PATIENTS: Starting a new course of an oral anti-cancer agent (the list of agents is posted to the CTSU website) other than sex hormone inhibitors, within 4 weeks after registration or have started an oral anti-cancer agent in the past 8 weeks.\n* PATIENTS: All concomitant medications and supportive care treatments are acceptable.\n* PATIENTS: Age ≥ 18 years.\n* PATIENTS: Able to speak and understand English or Spanish.\n* PATIENTS: Access to a telephone and ability to answer questions via telephone in English or Spanish.\n* PATIENTS: The patient must provide study-specific informed consent prior to study entry and authorization permitting release of personal health information.\n\nExclusion Criteria:\n\n* PRACTICES: Active telephone symptom management program at the practice that is beyond symptom and oral agent adherence monitoring.\n* PATIENTS: Only receiving treatment with sex hormone inhibitors.\n* PATIENTS: Enrollment in the intervention arm of another symptom management trial at intake into the trial. Participation in lifestyle trials with primary outcomes other than symptoms is acceptable.\n* PATIENTS: Currently receiving regular behavioral counseling for psychological symptoms. Regular behavioral counseling is defined as at least two counseling sessions with a behavioral health care provider scheduled within the past two months. Patients who completed behavioral counseling within 2 months prior to registration are eligible. Behavioral counseling for issues other than psychological symptoms (e.g., as part of weight loss or smoking cessation program) is not an exclusion criterion.\n* PATIENTS: Pregnancy at intake into the trial.",true,{"count":320,"type":23},600,[119],"In this clinical trial, symptom monitoring (interactive voice response \\[IVR\\] is compared to automated telephone symptom management \\[ATSM\\] and telephone interpersonal counseling \\[TIPC\\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes.",[324,325],"Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm",{"date":172,"type":39},{"date":328,"type":39},"2024-10-14",{"date":330,"type":23},"2028-05-01",{"name":45,"class":46},34,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":340,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":24,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100511958","phase-3-testing-shorter-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-with-high-risk-prostate-cancer-100511958","NCT05946213","Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer","The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer\n* High-risk disease defined as having at least one or more of the following:\n\n  * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[Ed.\\]) Note: cT4 by imaging or on digital rectal exam is not allowed\n  * The patient's prostate specific antigen (PSA) value \\> 20 ng\u002FmL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors\n  * Gleason Score of 8-10\n  * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm\n* Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan\n* No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* No prior radical prostatectomy\n* No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \\[HIFU\\], laser ablation, cryotherapy, irreversible electroporation \\[IRE\\], and vascular-targeted photodynamic therapy)\n* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \\[LHRH\\] agonist and oral anti-androgen) is =\\\u003C 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease\n* No contraindication to prostate MRI (required for planning of radiotherapy in both arms)\n* Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy","MALE",{"count":342,"type":23},1209,[26],"This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.",[346,347,348],"Prostate Adenocarcinoma","Stage III Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8",{"date":172,"type":39},{"date":351,"type":39},"2023-12-14",{"date":353,"type":23},"2036-03-31",{"name":45,"class":46},413,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":377},"100487277","phase-3-testing-the-addition-of-high-dose-targeted-radiation-to-the-usual-treatment-for-locally-advanced-inoperable-non-small-cell-lung-cancer-100487277","NCT05624996","Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer","Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer \\[AJCC\\] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration\n\n  * Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial\u002Fhilar\u002Fintrapulmonary, mediastinal\u002Fsubcarinal, supraclavicular\u002Fscalene)\n  * Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible\n  * Patients who refuse surgery, in addition to those who are technically unresectable or medically inoperable, are eligible.\n  * Patients with separate tumor nodules in the same lobe of the primary tumor are eligible\n* The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:\n\n  * History\u002Fphysical examination prior to registration;\n  * Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration;\n  * CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET\u002FCT may be used if the CT portion is of identical diagnostic quality as achieved in a stand-alone CT\n* No evidence of distant metastases based on FDG PET\u002FCT scan obtained within 60 days of registration\n* Primary tumor =\\\u003C 7 cm\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy\n* Creatinine clearance \\>= 25 mL\u002Fmin by the Cockcroft-Gault (C-G) equation\n* Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion\n\n  * If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:\n\n    * When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative;\n    * Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible\n* Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR\u002FALK\u002Fother driver mutation at the time of registration are eligible, and these patients can be treated with consolidation systemic therapy at the discretion of the treating physician\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Negative pregnancy test =\\\u003C 14 days prior to registration for participants of childbearing potential\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Prior radiotherapy to the study cancer (local recurrence). Prior radiotherapy for a different cancer\u002Fcondition to the region of the study cancer that would result in overlap of radiation therapy fields that is determined by the treating physician to impede the treatment of the study malignancy\n* Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required, but pathologic confirmation of involvement is not mandated\n* Centrally located primary tumor \\\u003C 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation fields. This does not include proximity to involved segmental and subsegmental lymph nodes (levels 13 and 14) that would not result in overlap of dose to the proximal bronchial tree or esophagus. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi)\n* Participants who are pregnant or unwilling to discontinue nursing\n* Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe required after the final dose of the selected systemic therapy regimen, because the treatment in this study may be significantly teratogenic",{"count":364,"type":23},474,[26],"This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy \\[IGRT\\] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation therapy to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation therapy that creates a picture of the tumor to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Usual chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds. Cisplatin works by killing, stopping, or slowing the growth of tumor cells. Carboplatin works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells as well. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Immunotherapy with durvalumab can induce changes in the body's immune system and can interfere with the ability of tumor cells to grow and spread. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Adding SBRT to the usual treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with locally-advanced non-small cell lung cancer than giving the usual treatment alone.",[368,369,370],"Locally Advanced Lung Non-Small Cell Carcinoma","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8",{"date":172,"type":39},{"date":373,"type":39},"2023-07-12",{"date":375,"type":23},"2031-10-15",{"name":45,"class":46},477,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":24,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":400},"100470667","phase-2-testing-the-use-of-ado-trastuzumab-emtansine-compared-to-the-usual-treatment-chemotherapy-with-docetaxel-plus-trastuzumab-or-trastuzumab-deruxtecan-for-recurrent-metastatic-or-unresectable-her2-expressing-salivary-gland-cancers-100470667","NCT05408845","Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers","A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent\u002Fmetastatic salivary gland cancer (SGC)\n\n  * HER2-positive cohort:\n\n    * Note: The majority of HER2-positive SGCs are salivary duct carcinoma (SDCs), but to a lesser extent, other SGC subtypes can be HER2-positive (e.g., adenocarcinomas, mucoepidermoid carcinomas, etc.) and are eligible to be included on the study. Additionally, pathologists may sign out SDCs under other descriptors (e.g., ex-pleomorphic adenoma, adenocarcinoma), and these would be eligible if they are HER2-positive.\n    * Note: HER2 evaluation based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local\u002Fcommercial next-generation sequencing (NGS) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for \"HER2-positive\":\n\n      * Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines\n      * Gene amplification by FISH (HER2\u002FCEP17 ratio \\>= 2.0)\n      * Gene amplification by NGS (fold change \\>= 2)\n  * HER2-low expressing cohort:\n\n    * Note: Local HER2 evaluation by immunohistochemistry (IHC) or fluorescent in-situ hybridization (FISH) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for \"HER2-low\":\n\n      * IHC 1+ per the College of American Pathologists (CAP) breast cancer guidelines\n      * IHC 2+ without evidence of amplification by FISH\n* Patients with unresectable disease who are not candidates for curative surgery or radiation OR recurrent OR metastatic disease that is evident on radiologic imaging\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n\n  * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* HER2-positive cohort: Measurable or non-measurable disease by the RECIST v1.1 criteria. HER2-low expressing cohort: Measurable disease by the RECIST v1.1 criteria\n* History\u002Fphysical examination within 30 days prior to registration\n* The following imaging within 60 days prior to registration:\n\n  * CT or MRI of the neck (diagnostic quality with contrast, unless contraindicated) AND\n  * CT scan of the chest (diagnostic quality with contrast, unless contraindicated) AND\n  * If clinically indicated, CT or MRI of the abdomen and pelvis (diagnostic quality with contrast, unless contraindicated)\n* Age \\>= 18\n* Left ventricular ejection fraction (LVEF) \\>= 50% assessed by echocardiogram or multigated acquisition (MUGA) scan within 30 days prior to registration\n* Zubrod (Eastern Cooperative Oncology Group \\[ECOG\\]) Performance Status of 0-2 within 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3 (within 14 days prior to registration)\n* Platelets \\>= 100,000 cells\u002Fmm\\^3 (within 14 days prior to registration)\n* Hemoglobin \\>= 9.0 g\u002FdL (within 14 days prior to registration)\n\n  * HER2-positive cohort: Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 9.0 g\u002FdL is acceptable\n  * HER2-low expressing cohort: Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (granulocyte colony-stimulating factor \\[G-CSF\\]) is not allowed\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) \\>= 30 mL\u002Fmin by the Cockcroft-Gault formula (within 14 days prior to registration)\n* HER2-positive cohort: Total bilirubin =\\\u003C 1.5 x ULN (within 14 days prior to registration) (Not applicable to patients with known Gilbert's syndrome) (within 14 days prior to registration)\n* HER2-positive cohort: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 1.5 x ULN (within 14 days prior to registration)\n* HER2-low expressing cohort: Total bilirubin ≤ 1.5 x ULN if no liver metastases; or \\\u003C 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases (within 14 days prior to registration) (within 14 days prior to registration)\n* HER2-low expressing cohort: AST and ALT ≤ 3 x ULN if no liver metastases; or \\\u003C 5 x ULN with liver metastases (within 14 days prior to registration)\n* HER2-low expressing cohort: Serum albumin ≥ 2.5 g\u002FdL (within 14 days prior to registration)\n* Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Testing is not required for entry into protocol\n* For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g., patients immunized against hepatitis B)\n* For patients with a known history of hepatitis C virus (HCV) infection, they must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\n  * Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 7 months following last dose of study drug; this inclusion is necessary because the treatment in this study may be significantly teratogenic. Women must refrain from donating eggs during this same period\n* Men with partners of childbearing potential must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and\u002For partner, and to continue the use of contraception for the duration of study treatment and for at least 7 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period\n* Prior to registration, patients who have had chemotherapy or palliative-intent radiotherapy must have all toxicities related to prior treatment recovered to ≤ grade 1\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* HER2-positive cohort: Prior systemic therapy for the study cancer in the unresectable or recurrent and\u002For metastatic disease setting\n\n  * Note: Prior chemotherapy for a different cancer is allowed; prior androgen receptor targeted therapy in any setting is allowed; prior systemic therapy, including HER2-directed therapies given as neoadjuvant therapy, adjuvant therapy, and\u002For concurrently with radiation is allowed\n* HER2-low expressing cohort: HER2 directed therapy for unresectable or recurrent or metastatic disease is not allowed\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina requiring hospitalization in the last 6 months\n  * Myocardial infarction within the last 6 months\n  * New York Heart Association Functional Classification III\u002FIV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing\n  * Patient must not have an active infection requiring IV antibiotics, antivirals, or antifungals\n* HER2-positive cohort only: \\>= grade 3 peripheral neuropathy\n* Interstitial lung disease or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on chest CT scan\n* Any hemorrhage or bleeding event grade \\>= 3 within 28 days prior to registration\n* History of allergic reactions to compounds of similar chemical or biologic composition to: HER2-positive cohort: ado-trastuzumab emtansine, trastuzumab, and\u002For docetaxel (or any of their excipients). HER2-low expressing cohort: DS-8201a (trastuzumab deruxtecan), trastuzumab\n* History of exposure to the following cumulative doses of anthracyclines:\n\n  * Doxorubicin or liposomal doxorubicin \\> 500 mg\u002Fm\\^2\n  * Epirubicin \\> 900 mg\u002Fm\\^2\n  * Mitoxantrone \\> 120 mg\u002Fm\\^2\n  * Note: If another anthracycline, or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of doxorubicin 500 mg\u002Fm\\^2\n* HER2-low expressing cohort only: Receipt of live, attenuated vaccine (messenger ribonucleic acid \\[mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of DS-8201a (trastuzumab deruxtecan)\n* Pregnancy and individuals unwilling to discontinue nursing",{"count":386,"type":23},146,[80],"This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.",[390,391,392,393,394],"Metastatic Salivary Gland Carcinoma","Recurrent Salivary Gland Carcinoma","Stage III Major Salivary Gland Cancer AJCC v8","Stage IV Major Salivary Gland Cancer AJCC v8","Unresectable Salivary Gland Carcinoma",{"date":172,"type":39},{"date":397,"type":39},"2023-03-03",{"date":283,"type":23},{"name":45,"class":46},152,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":24,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"100464437","phase-2-testing-the-addition-of-stereotactic-radiation-therapy-with-immune-therapy-for-the-treatment-of-patients-with-unresectable-or-metastatic-renal-cell-cancer-samurai-trial-100464437","NCT05327686","Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial","Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)","SAMURAI","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration\n* Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 45 days prior to registration\n  * CT\u002Fmagnetic resonance imaging (MRI) of the chest\u002Fabdomen\u002Fpelvis within 45 days prior to registration\n* Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\\>= 3 factors)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor\n* Patient not recommended for or refused immediate cytoreductive nephrectomy\n* Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen\n* Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging\n* Age \\>= 18\n* Karnofsky performance status \\>= 60 within 45 days prior to registration\n* Hemoglobin \\>= 8 g\u002FdL (transfusions are allowed) (within 45 days prior to registration)\n* Platelet count \\>= 50,000\u002Fmm\\^3 (within 45 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (within 45 days prior to registration)\n* Calculated (Calc.) creatinine clearance \\>= 30 mL\u002Fmin (within 45 days prior to registration)\n\n  * Creatinine clearance (CrCl) \\>= 30 mL\u002Fmin estimated by Cockcroft-Gault Equation\n  * For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR \\>= 30 mL\u002Fmin\u002F1.73m\\^2 will be considered adequate\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL) (within 45 days prior to registration)\n* Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =\\\u003C 3 x upper limit of normal (ULN) or \\\u003C 5 x ULN if hepatic metastases present (within 45 days prior to registration)\n* Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment\n* Patients with untreated or unstable brain metastases or cranial epidural disease\n\n  * Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator\n* Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor\n* Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated \\> 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed \\> 3 years prior to registration)\n* Severe, active comorbidity defined as follows:\n\n  * Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n  * History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies\n  * Active tuberculosis (purified protein derivative \\[PPD\\] response without active tuberculosis \\[TB\\] is allowed)\n  * Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\>= 190 mmHg or diastolic BP \\> 110 mmHg)\n  * Major surgery requiring hospital admission =\\\u003C 28 days prior to registration\n  * Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration\n  * Any arterial thrombotic (ST elevation myocardial infarction \\[STEMI\\], non-ST elevation myocardial infarction \\[NSTEMI\\], cerebrovascular accident \\[CVA\\], etc) events within 180 days prior to registration\n  * Active New York (NY) Heart Association class 3-4 heart failure symptoms\n  * Moderate or severe hepatic impairment (Child-Pugh B or C)\n  * Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis \\> 30 days prior to registration is allowed)\n  * Unstable cardiac arrhythmia within 180 days prior to registration\n  * History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration\n  * History of or active inflammatory bowel disease\n  * Malabsorption syndrome within 45 days prior to registration\n* Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =\\\u003C 45 days prior to registration",{"count":410,"type":23},240,[80],"This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.",[301,414,302,415],"Stage III Renal Cell Cancer AJCC v8","Unresectable Renal Cell Carcinoma",{"date":172,"type":39},{"date":418,"type":39},"2023-02-01",{"date":420,"type":23},"2028-06-15",{"name":45,"class":46},328,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":24,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100388112","phase-2-comparing-sentinel-lymph-node-sln-biopsy-with-standard-neck-dissection-for-patients-with-early-stage-oral-cavity-cancer-100388112","NCT04333537","Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer","Randomized Phase II\u002FIII Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION INCLUSION:\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration\n* Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[ed.\\]) based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 42 days prior to registration\n  * Imaging of head and neck within 42 days prior to registration\n\n    * PET\u002FCT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended as part of the PET\u002FCT when possible\n  * Imaging of chest within 42 days prior to registration\n\n    * Chest x-ray, CT chest scan (with or without contrast), or PET\u002FCT (with or without contrast)\n* Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)\n\n  * Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins\n* Age \\>= 18\n* Zubrod performance status 0-2 within 42 days prior to registration\n* For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* Only patients who are able to read and understand English or French are eligible to participate as the mandatory patient reported NDII tool is only available in these languages\n* PRIOR TO STEP 2 RANDOMIZATION:\n* FDG PET\u002FCT required prior to step 2. Note: FDG PET\u002FCT done prior to step 1 can be submitted for central review\n\n  * PET\u002FCT node negative patients, determined by central read, will proceed to randomization. PET\u002FCT node positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development\n\n    * NOTE: All FDG PET\u002FCT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)\n* The patient must complete NDII prior to step 2 registration\n\nExclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION EXCLUSION:\n* Definitive clinical or radiologic evidence of regional (cervical) and\u002For distant metastatic disease\n* Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years\n* Diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, and larynx\n* Unable or unwilling to complete NDII (baseline only)\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Severe, active co-morbidity that would preclude an elective or completion neck dissection\n* Pregnancy and breast-feeding mothers\n* Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted\n* Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are \\>= 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound (U\u002FS)-guided fine-needle aspiration (FNA) biopsy\n* Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \\[CLL\\]) or other active disease capable of causing lymphadenopathy (e.g., sarcoidosis or untreated mycobacterial infection)\n* Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy\n* Currently participating in another investigational therapeutic trial",{"count":431,"type":23},686,[80,26],"This phase II\u002FIII trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.",[435,436,437,438,439,440,222,441,231,237,442,443],"Buccal Mucosa Squamous Cell Carcinoma","Floor of Mouth Squamous Cell Carcinoma","Gingival Squamous Cell Carcinoma","Hard Palate Squamous Cell Carcinoma","Lip Squamous Cell Carcinoma","Lower Alveolar Ridge Squamous Cell Carcinoma","Retromolar Trigone Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Upper Alveolar Ridge Squamous Cell Carcinoma",{"date":172,"type":39},{"date":446,"type":39},"2020-09-23",{"date":448,"type":23},"2031-04-27",{"name":45,"class":46},107,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100347294","phase-3-comparing-proton-therapy-to-photon-radiation-therapy-for-esophageal-cancer-100347294","NCT03801876","Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer","Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)\n* Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:\n\n  * History\u002Fphysical examination\n  * Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)\u002Fcomputed tomography (CT) with or without contrast (preferred) or chest\u002Fabdominal (include pelvic if clinically indicated) CT with contrast\n\n    * For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration\n    * For patients who DID receive induction chemotherapy, scan must occur:\n\n      * Within 30 days after final induction chemotherapy dose; OR\n      * Within 30 days prior to Step 1 registration\n    * Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible\n* Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation\n* Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration; only FOLFOX, CAPOX, durvalumab-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) (D-FLOT) and FLOT will be allowed as the induction chemotherapy regimen\n* Age ≥ 18\n* Zubrod performance status 0, 1, or 2\n* Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration)\n\n  * For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells\u002Fmm\\^3\n  * For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells\u002Fmm\\^3\n* Platelets (within 30 days prior to Step 1 registration)\n\n  * For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000\u002FuL\n  * For patients who DID receive induction chemotherapy: Platelets ≥ 75,000\u002FuL\n* Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable) (within 30 days prior to Step 1 registration)\n* Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance \\> 40 mL\u002Fmin estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration)\n* Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* Cervical esophageal cancers arisen from 15-18 cm from the incisors\n* Patients with T4b disease according to the AJCC 8th edition\n* Definitive clinical or radiologic evidence of metastatic disease\n* Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment\n* Prior thoracic radiotherapy that would result in overlap of radiation therapy fields\n* Severe, active co-morbidity defined as follows:\n\n  * Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration\n  * Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration\n  * Myocardial infarction within 3 months prior to Step 1 registration\n* Pregnant and\u002For nursing females\n* Human immunodeficiency virus (HIV) positive with CD4 count \\\u003C 200 cells\u002Fmicroliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells\u002Fmicroliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive\n* PRIOR TO STEP 2 REGISTRATION:\n* Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment",{"count":459,"type":23},300,[26],"This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.",[463,464,465,466,467,468,469,470,471,472,473,474,475],"Clinical Stage I Esophageal Adenocarcinoma AJCC v8","Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8","Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Thoracic Esophagus Squamous Cell Carcinoma",{"date":172,"type":39},{"date":478,"type":39},"2019-06-26",{"date":480,"type":23},"2031-12-21",{"name":45,"class":46},96,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":24,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":503},"100299608","phase-3-observation-or-radiation-therapy-in-treating-patients-with-newly-diagnosed-grade-ii-meningioma-that-has-been-completely-removed-by-surgery-100299608","NCT03180268","Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery","Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria\n* Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibility)\n* Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection\n* GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration. The post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery. Computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* NOTE: Central pathology review must occur between steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 10 business days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization\n* PRIOR TO STEP 2 REGISTRATION:\n* Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration\n* Age \\>= 18\n* History\u002Fphysical examination, including neurologic examination within 60 days prior to step 2 registration\n* Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration\n* If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception\n\nExclusion Criteria:\n\n* Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma\n* Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)\n* Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas\n* Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and\u002For preclude informed consent; these include, but are not restricted to:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization at the time of step 2 registration\n  * Transmural myocardial infarction within the last 6 months prior to step 2 registration\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration\n  * Type II neurofibromatosis (NF2)\n  * Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count \\\u003C 200 cells\u002Fmicroliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \\>= 200 cells\u002Fmicroliter within 30 days prior to step 2 registration\n  * Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction). Note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia",{"count":491,"type":23},163,[26],"This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.",[495,496],"Grade 2 Meningioma","Intracranial Meningioma",{"date":172,"type":39},{"date":499,"type":39},"2017-09-12",{"date":501,"type":23},"2027-06-15",{"name":45,"class":46},215,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":518,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":4},"100627732","phase-3-temporally-modulated-pulsed-radiation-therapy-versus-standard-radiation-therapy-for-the-treatment-of-newly-diagnosed-idh-wildtype-mgmt-unmethylated-glioblastoma-100627732","NCT07452458","Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, IDH Wildtype, MGMT-Unmethylated Glioblastoma","A Randomized Phase III Study Comparing Temporally-Modulated Pulsed Radiation Therapy (TMPRT) Versus Standard Radiation Therapy With Temozolomide for Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered).\n* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis. Note that tissue for central pathology review and central MGMT assessment must be shipped to the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be shipped by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be completed within 10 business days of receipt of tissue. Results will be entered by the central lab directly into Rave. Note: In the event of an additional tumor resection(s), tissue must be shipped within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection.\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to Step 1 registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* No known leptomeningeal disease or metastatic disease outside the brain.\n* Age ≥ 18\n* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.\n* Karnofsky Performance Status ≥ 70\n* Hemoglobin ≥ 10 g\u002Fdl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 10.0 g\u002Fdl is acceptable)\n* Leukocytes ≥ 2,000\u002Fmm\\^3 OR absolute neutrophil count ≥ 1,500\u002Fmm\\^3\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3 x ULN\n* No prior cranial radiation therapy that would result in overlap of radiation therapy fields.\n* No previous therapy for GBM except surgery, laser interstitial thermal therapy (LITT) or Gliadel wafer.\n\n  * Note: 5-aminolevulinic acid (ALA)-mediated fluorescence-guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to\u002Fduring surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent.\n* No history of unstable angina requiring hospitalization in the last 3 months\n* No history of myocardial infarction within the last 3 months\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)\n* No active infection currently requiring IV antibiotic management\n* No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy\n* No movement disorder that could impede ability to lie still with an immobilization mask for approximately 40 minutes\n* No significant sensory deficits (i.e., blindness, mutism) that would prohibit participation of NCF testing\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to temozolomide\n* PRIOR TO STEP 2 REGISTRATION:\n* The following baseline neurocognitive tests must be completed within 28 days prior to Step 2 registration: (Hopkins Verbal Learning Test - Revised \\[HVLT-R\\], Trail Making Test \\[TMT\\], Controlled Oral Word Association \\[COWA\\]). The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. The following scores must be obtained for patient eligibility: HVLT-R Total Recall \\> 5, HVLT-R Delayed Recall \\> 3, HVLT-R Delayed Recognition \\> -10, TMT Part A . 2738, TMT Part B . 3724, COWA . 12. Central review of the Neurocognitive tests will be completed in Rave within 3 business days after the upload is completed. Users with the Rave clinical research associate (CRA) role will be able to view the results in Rave. The CRA must confirm that the results are available and meet eligibility requirements prior to proceeding with Step 2 Registration.\n\n  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n  * Note: Patients whose neurocognitive test scores do not meet the criteria above will not be eligible for the study and will be reported as ineligible due to \"Failure to meet Neurocognitive testing criteria\" on Step 2 registration.\n* Pathology proven diagnosis of IDH-wildtype glioblastoma with unmethylated MGMT promoter confirmed by central pathology review. IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e. IDH-wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2.)\n\n  * Central pathology review will generally be completed within 10 business days of receipt of the tissue. Users with the Rave CRA role will be able to view the results in Rave. It must be confirmed that the results are available and meet eligibility requirements prior to proceeding with Step 2 Registration.\n  * Note: Patients with tissue that is insufficient or inadequate for analysis, has failed MGMT testing, or has indeterminate or methylated MGMT promoter are excluded and will be reported as a \"central pathology review failure\" on step 2 registration.",{"count":512,"type":23},398,[26],"This phase III trial compares temporally-modulated pulsed radiation therapy versus standard radiation therapy in treating patients with newly diagnosed, IDH wildtype, MGMT-unmethylated glioblastoma. After completion of surgery, the standard of care for glioblastoma is radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. For older and frail patients, standard treatment also includes the chemotherapy drug temozolomide. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Approximately 70% of glioblastoma patients have MGMT-unmethylated status. MGMT unmethylated tumors are less likely to respond to temozolomide chemotherapy, so there is more reliance on radiation therapy to kill the tumor cells. Recent clinical trials studying new therapies for MGMT-unmethylated glioblastoma have failed to improve outcomes over temozolomide. These recent studies also indicate that 80% of patients experience a decline in memory and thinking function after treatment. TMPRT differs from standard radiation therapy by delivering the same amount of radiation dose in 10-13 \"pulses\" with 3-minute breaks between pulses. TMPRT with temozolomide may work better than standard radiation therapy with temozolomide in increasing survival, as well as improving memory and thinking function in patients with newly diagnosed, IDH wildtype, MGMT-unmethylated glioblastoma.",[516,517],"Glioblastoma, IDH-Wildtype","MGMT-Unmethylated Glioblastoma","NOT_YET_RECRUITING","2026-04-28",{"date":521,"type":39},"2026-05-04",{"date":523,"type":23},"2026-06-08",{"date":525,"type":23},"2031-07-15",{"name":45,"class":46},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":24,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":518,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":4},"100626903","phase-3-comparing-radiation-plus-cetuximab-to-radiation-plus-chemotherapy-in-people-with-head-and-neck-cancer-who-cannot-receive-cisplatin-100626903","NCT07441681","Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive Cisplatin","Radiotherapy With Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients With Stage III-IVB Head and Neck Cancer With a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial","Inclusion Criteria:\n\n* Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity\n* Local evaluation of p16 status is required for all oropharynx patients prior to registration\n* Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration\n* Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as:\n\n  * Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 8th edition stage III-IVB\n\n    * Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries:\n\n      * AJCC 8th Edition TNM: T3-4b N0 M0 AJCC 8th Edition Stage: III-IVB\n      * AJCC 8th Edition TNM: T1-4b N1-3 M0 AJCC 8th Edition Stage: III-IVB\n  * p16-positive oropharynx cancer: AJCC 8th edition stage III and selected stage I-II based on smoking status in pack-years\n\n    * Eligible p16-Positive Oropharyngeal Primaries\n\n      * AJCC 8th Edition TNM: T1-2 N1 M0 AJCC 8th Edition Stage: I Pack-Years: \\> 10\n      * AJCC 8th Edition TNM: T1-2 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any\n      * AJCC 8th Edition TNM: T3 N0-1 M0 AJCC 8th Edition Stage: II Pack-Years: \\> 10\n      * AJCC 8th Edition TNM: T3 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any\n      * AJCC 8th Edition TNM: T1-3 N3 M0 AJCC 8th Edition Stage: III Pack-Years: any\n      * AJCC 8th Edition TNM: T4 N0-3 M0 AJCC 8th Edition Stage: III Pack-Years: any\n\n        * Note: Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20\n        * Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation\n* The following are required prior to registration:\n\n  * Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET\u002FCT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated)\n  * Chest imaging: Chest CT (with contrast, unless contraindicated) or PET\u002FCT\n* Age ≥ 18\n* Complete the online tool at www.nrgoncology.org prior to registration and record the (modified) Charleston Comorbidity Index (CCI), Head and Neck Cancer Intergroup (HNCIG) omega, and G-8 scores on the registration form in Oncology Patient Enrollment Network (OPEN)\n* Patients must have a contraindication to cisplatin as defined in the following bullet points:\n\n  * Absolute or relative contraindication to cisplatin, defined as ONE OR MORE of the following prior to registration:\n\n    * Creatinine clearance (CrCl) \\\u003C 60 mL\u002Fmin by the Cockroft-Gault formula\n    * Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\] 5.0)\n    * History of hearing loss, defined as either:\n\n      * Existing need of a hearing aid OR\n      * ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR\n  * age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \\\u003C 0.80 prior to registration OR\n  * Age \\\u003C 70 with ALL of the following conditions prior to registration (see Appendix II for calculation instructions):\n\n    * HNCIG omega score \\\u003C 0.80\n    * (Modified) Charlson Comorbidity Index (CCI) ≥ 1\n    * G-8 score ≤ 14\n* Not pregnant and not nursing\n* Participants must be able to safely receive the radiation and drug regimens per current Food and Drug Administration (FDA)-approved package insert(s), treating investigator's discretion, and institutional guidelines\n* No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable\n* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* No prior surgery for the study cancer",{"count":535,"type":23},454,[26],"This phase III trial compares cetuxumab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer who are unable to receive cisplatin. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. It is not yet know if cetxiumab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with head and neck cancer who are unable to receive cisplatin.",[215,216,217,218,241,242,243,245,246,247,248,250,251,252,253,254],{"date":521,"type":39},{"date":541,"type":23},"2027-01-06",{"date":543,"type":23},"2035-11-30",{"name":45,"class":46},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":566},"100600411","phase-3-testing-shorter-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-receiving-the-usual-chemotherapy-treatment-for-bladder-cancer-archer-study-100600411","NCT07097142","Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study","The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)","Inclusion Criteria:\n\n* Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.\n\n  * Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible\n* Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection\n* Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fluorodeoxyglucose (FDG) PET imaging is acceptable for radiological staging\n* If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT \u002F MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement prior to randomization\n* No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy\n* No definitive clinical or radiologic evidence of metastatic disease\n* Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta\u002FT1\u002FCarcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy\n* Age ≥ 18\n* Zubrod performance status of ≤ 2\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\]) ≥ 8.0 g\u002Fdl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization\n* For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization\n* Must not have had prior pelvic radiation\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection requiring IV antibiotics\n* Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified",{"count":553,"type":23},486,[26],"This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.",[557,558,559],"Muscle Invasive Bladder Urothelial Carcinoma","Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8",{"date":521,"type":39},{"date":562,"type":39},"2025-10-07",{"date":564,"type":23},"2030-05-31",{"name":45,"class":46},211,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":24,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":589},"100508114","cognitive-training-for-cancer-related-cognitive-impairment-in-breast-cancer-survivors-100508114","NCT05896189","Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors","Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial","Inclusion Criteria:\n\n* The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information.\n* The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III.\n* The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.\n* Participants must be at least 6 months and no more than 5 years (after completion of initial surgery +\u002F- adjuvant chemotherapy\u002Fradiation therapy) and targeted therapies (e.g., PARP inhibitors, CDK4\u002F6, or immunotherapy). Participants may still be taking endocrine therapy and\u002For trastuzumab.\n* The participant must be able to understand, speak, read, and write in English or Spanish.\n\nExclusion Criteria:\n\n* Scoring less than or equal to 3 on the 6-item cognitive screen.\n* Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3.\n* Definitive clinical or radiologic evidence of metastatic disease.\n* Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.\n* Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis).\n* Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery.\n* Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia.\n* Participants with active substance abuse and\u002For in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.\n* Participants who are enrolled in an active behavioral intervention (e.g., occupational therapy, physical therapy, etc.) or pharmaceutical intervention or who are in the follow-up phase of a cancer control trial or therapeutic trial that has extensive PRO follow-up after treatment ends. Participants who are enrolled in a therapeutic trial in which they have completed active treatment and require only minimal follow-up monitoring of toxicity and\u002For survival analysis (cancer-related mortality or all-cause mortality) would be eligible.\n* Hearing impairment unless adequately corrected with hearing aids to be able to hear over the phone for the neuropsychological testing.","100 Years",{"count":576,"type":23},386,[119],"This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.",[29,580],"Cognitive Impairments","2026-04-22",{"date":583,"type":39},"2026-04-23",{"date":585,"type":39},"2024-02-29",{"date":587,"type":23},"2027-11-30",{"name":45,"class":46},680,{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":115,"enrollmentInfo":598,"targetDuration":4,"studyType":24,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100427966","phase-3-de-escalation-of-breast-radiation-trial-for-hormone-sensitive-her-2-negative-oncotype-recurrence-score-less-than-or-equal-to-18-breast-cancer-debra-100427966","NCT04852887","De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)","A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer","DEBRA","Inclusion Criteria:\n\n* • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry\u002FStep 1 and, for patients treated in the U.S., authorization permitting release of personal health information.\n\n  * The patient must have an ECOG performance status of 0 or 1.\n  * The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.)\n  * The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.\n  * Patient must have undergone axillary staging (sentinel node biopsy and\u002For axillary node dissection).\n  * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:\n  * By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm).\n  * By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)\n  * Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.\n\n    \\*\\* For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry\u002FStep 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis.\n\n    \\*\\*\\* The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection.\n  * An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary \"Low\" category will meet this eligibility criteria and an Oncotype RS does not need to be performed.\n  * The tumor must have been determined to be ER and\u002For PgR positive assessed by current ASCO\u002FCAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive.\n  * The tumor must have been determined to be HER2-negative by current ASCO\u002FCAP guidelines.\n  * Patients may be premenopausal or postmenopausal at the time of pre-entry\u002FStep 1. For study purposes, postmenopausal is defined as:\n  * Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry\u002FStep 1; or a documented hysterectomy; or\n  * Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry\u002FStep 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional\u002Flaboratory standard; or Documented bilateral oophorectomy.\n  * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry\u002FStep 1 must be no more than 70 days.\n  * The patient must have recovered from surgery with the incision completely healed and no signs of infection.\n  * Bilateral mammogram or MRI within 6 months prior to pre-entry\u002FStep 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.\n\nExclusion Criteria:\n\n* • Definitive clinical or radiologic evidence of metastatic disease.\n\n  * pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.\n  * Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.\n  * Patient had a mastectomy.\n  * Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.\n  * Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.\n  * Non-epithelial breast malignancies such as sarcoma or lymphoma.\n  * Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)\n  * Paget's disease of the nipple.\n  * Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)\n  * Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and\u002For previous contralateral LCIS are eligible.)\n  * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)\n  * Treatment plan that includes regional nodal irradiation.\n  * Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry\u002FStep 1.\n  * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry\u002FStep 1.\n  * Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention.\n\n    \\*\\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization\u002FStep 2) for this diagnosis after the core biopsy (and can continue postoperatively if:\n  * the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND\n  * the patient had not initiated endocrine therapy prior to core biopsy tissue collection.\n\n    \\*\\*\\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry\u002FStep 1).\n  * Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.\n  * Prior breast or thoracic RT for any condition.\n  * Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.\n  * Pregnancy or lactation at the time of pre-entry\u002FStep 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry\u002FStep 1.)\n  * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n  * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.\n  * Use of any investigational product within 30 days prior to pre-entry\u002FStep 1.",{"count":599,"type":23},1670,[26],"This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.",[603],"Stage I Breast Cancer",{"date":583,"type":39},{"date":606,"type":39},"2021-06-23",{"date":608,"type":23},"2041-07",{"name":45,"class":46},832,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":56,"minAge":619,"maxAge":620,"enrollmentInfo":621,"targetDuration":4,"studyType":24,"phases":623,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":518,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":632,"leadSponsor":634,"locationsCount":4},"100635583","phase-3-assessment-of-biosignature-classification-of-dcis-for-radiotherapy-benefit-post-lumpectomy-abcd-rt-100635583","NCT07554573","Assessment of Biosignature Classification of DCIS for RadioTherapy Benefit Post Lumpectomy (ABCD RT)","Phase III Randomized Trial: Assessment of Biosignature Classification of DCIS for RadioTherapy Benefit Post Lumpectomy (ABCD RT)","ABCD RT","Inclusion Criteria:\n\n* The patient or a legally authorized representative must provide study-specific informed consent prior to Step 1\u002FRegistration and, for patients treated in the U.S., authorization permitting release of personal health information.\n\nBreast and Disease Assessment\n\n* The patient must be female and greater than or equal to 30 and less than or equal to 85 years of age. (Note: The DCISionRT test is validated only in women between the ages of 30 and 85.)\n* The patient must have a diagnosis of DCIS less than or equal to 6 cm. (Note: The DCISionRT test is validated only in women with DCIS less than or equal to 6 cm.)\n* The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 50%).\n* The patient must have had a bilateral mammogram within 6 months prior to registration.\n* The patient must have undergone breast conserving surgery with negative surgical margins (greater than or equal to 2 mm). Margin status is assessed on lumpectomy specimen and\u002For additional margins as determined by the local pathologist. If pathologic examination demonstrates DCIS less than 2 mm from resection edge, additional excisions may be performed to obtain clear margins. Patients with lobular carcinoma in situ (LCIS), atypical lobular hyperplasia (ALH), and\u002For atypical ductal hyperplasia (ADH) are eligible regardless of margins for these histologies.\n* The patient must have no suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.\n* The interval between the last surgery for DCIS (including re-excision of margins) and registration must be no more than 70 days\n* The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:\n* Primary tumor must be pTis\n* Patients must be cN0 (by physical exam and\u002For imaging)\n* Axillary surgery staging with sentinel node biopsy and\u002For axillary node dissection is not required. If surgical axillary staging was performed, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0 (i+) or pN0)(mol+) are NOT eligible.\n* DCIS may be of any grade (1-3).\n* The DCIS must be tested for estrogen receptor (ER) and progesterone receptor (PgR) status, either on an initial core biopsy or surgical specimen, by current ASCO\u002FCAP Guideline Recommendations for hormone receptor testing. Any ER and\u002For PgR receptor status is eligible.\n* Participants must have unilateral DCIS diagnosed within 4 months of registration without a history of prior ipsilateral or contralateral DCIS or invasive breast cancer.\n* DCISionRT result must have been either previously obtained or the patient has consented to submission of specimen for centralized testing by PreludeDx.\n* The patient must have recovered from surgery with the incision well healed and no signs of infection.\n* The patient must have no contraindications to standard-of-care breast radiotherapy (i.e., active collagen-vascular disease, scleroderma, prior breast\u002Fchest radiotherapy).\n\nCo-morbid and Other Conditions\n\n* Patients of childbearing potential must have a negative pregnancy test within 14 days of registration, have no intention of becoming pregnant for 120 days following registration and be willing to use highly effective contraception if randomized to RT from registration until 1 month after completion of RT.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the treatment regimen are eligible for this trial.\n* If germ-line testing performed, results must be reviewed and indicate no pathogenic or likely pathogenic variants associated with increased breast cancer risk. (Variants of unknown significance are acceptable.)\n\nMedications\n\n* Patients must discontinue postmenopausal hormone replacement therapy, including estrogens or progesterone formulations prior to study entry. Low-dose vaginal estrogen creams, tablets, rings, or IUDs are allowed. For patients treated with anti-endocrine therapy as chemoprevention for the development of breast cancer, anti-endocrine therapy must have been discontinued greater than 6 months prior to the diagnosis of DCIS.\n* Adjuvant anti-endocrine therapy is a standard treatment option for ER or PgR positive DCIS. Patients may not have a history of taking oral anti-endocrine therapy (SERMS, SERDS, or aromatase inhibitors) prior to DCIS diagnosis. Adjuvant anti-endocrine therapy for DCIS may not be initiated prior to DCISion RT testing.","30 Years","85 Years",{"count":622,"type":23},5270,[26],"NRG-CC016 is being done to determine if omission of radiation therapy (RT) for patients with biosignature Low Risk (DCISionRT score less than 2.8) DCIS yields no clinically meaningful increase ipsilateral breast recurrence (IBR) compared to those treated with RT (Cohort A).",[29],[29,627,628],"Radiation Therapy","Ductal Carcinoma in Situ (DCIS)","2026-04-21",{"date":519,"type":39},{"date":147,"type":23},{"date":633,"type":23},"2048-07-31",{"name":45,"class":46},{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":24,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":664},"100560681","phase-3-testing-olaparib-for-one-or-two-years-with-or-without-bevacizumab-to-treat-ovarian-cancer-100560681","NCT06580314","Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer","A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1\u002F2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy","Inclusion Criteria:\n\n* Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:\n\n  * High grade serous\n  * High grade endometrioid, and\u002For\n  * Other epithelial ovarian cancer with BRCA1\u002F2 deleterious alteration (germline or somatic)\n  * Submission of pathology report is required\n  * Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer\n* Patients must have:\n\n  * Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)\n\n    * Submission of testing report is required. OR\n  * BRCA 1\u002F2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)\n\n    * Submission of testing report is required\n* Patient must have undergone cytoreductive surgery (primary or interval)\n* Patients must have completed first line platinum-based therapy prior to registration:\n\n  * Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated\n\n    * For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy\n  * Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle\n  * Patients must not have received an investigational agent during their first line course of chemotherapy\n* Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)\n* Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)\n* No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002Fdl\n* Creatinine clearance (CrCL) of \\> 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parental antibiotic(s)\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No current inability to swallow orally administered medication\n* No history of myelodysplastic syndrome and\u002For acute myeloid leukemia\n* No history of allogeneic bone marrow transplant\n* No concomitant use of strong or moderate CYP3A inducers\n* No known hypersensitivity to olaparib or any of the excipients of the product",{"count":643,"type":23},880,[26],"This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1\u002F2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1\u002F2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.",[647,648,649,650,651,652,653,654,655],"Fallopian Tube Endometrioid Adenocarcinoma","Fallopian Tube High Grade Serous Adenocarcinoma","FIGO Stage III Ovarian Cancer 2014","FIGO Stage IV Ovarian Cancer 2014","Ovarian Carcinoma","Ovarian High Grade Endometrioid Adenocarcinoma","Ovarian High Grade Serous Adenocarcinoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal High Grade Serous Adenocarcinoma","2026-03-23",{"date":658,"type":39},"2026-03-24",{"date":660,"type":39},"2025-03-12",{"date":662,"type":23},"2034-12-31",{"name":45,"class":46},676,""]