[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ECOG-ACRIN Cancer Research Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":367},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,49,70,91,113,136,157,180,202,226,246,266,287,321],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100593077","phase-2-testing-the-addition-of-paclitaxel-administered-into-the-abdominal-cavity-combined-with-chemotherapy-for-patients-with-gastric-cancer-spread-to-the-abdominal-cavity-100593077",false,"NCT07001748","Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity","Protocol EA2234: A Randomized Phase II\u002FIII Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II","STOPGAP II","STEP 0 REGISTRATION:\n\n* Patient must be at least 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H\u002FdMMR) mismatch repair deficient disease are not eligible\n* Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment\n* Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy\n* Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy\n* Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration\n* Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy\n* Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy\n* Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement\n* Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration\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 II or better\n* Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin\n* Leukocytes ≥ 2,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (≤ 30 days prior to Step 0 registration)\n* Platelets ≥ 75,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \\\u003C 2.0 mg\u002FdL (≤ 30 days prior to Step 0 registration)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration)\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)\n* Hemoglobin ≥ 8 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Serum albumin ≥ 2.5 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial\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. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\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* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n\nSTEP 1 RANDOMIZATION:\n\n* Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained\n* The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available\n* Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port","ALL","18 Years",{"count":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study is being done to answer the following questions:\n\nCan we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer.\n\nIf you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below.\n\nIf you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen).\n\nIf you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment.\n\nIt is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in.\n\nOnce you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon.\n\nThere is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called \"intra-abdominal adhesions\". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help.\n\nAfter you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest\u002FAbdomen\u002FPelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.",[28,29,30],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Peritoneal Carcinomatosis",[32,33,15,34,35],"EA2234","Intraperitoneal Paclitaxel","STOPGAP I","Gastric Carcinomatosis","RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-17","ACTUAL",{"date":42,"type":40},"2025-08-19",{"date":44,"type":21},"2030-05-30",{"name":46,"class":47},"ECOG-ACRIN Cancer Research Group","NETWORK",55,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100552661","phase-3-study-of-targeted-therapy-vs-chemotherapy-in-patients-with-thyroid-cancer-100552661","NCT06475989","Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer","A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient must have differentiated thyroid cancer (DTC) with BRAF V600E mutation as determined by local testing, including the following subtypes (Note: results of a previous biopsy will be accepted):\n\n  * Papillary thyroid carcinoma including histological variants of papillary thyroid carcinoma (PTC) such as follicular variant, tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated.\n  * Follicular thyroid carcinoma including histological variants of follicular thyroid carcinoma (FTC) such as Hürthle cell, clear cell, insular, and poorly differentiated\n* Patient must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC, and must be receiving thyroxine suppression therapy\n* Patient must have had prior treatment with at least one of the following vascular endothelial growth factor receptors (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib.\n\n  * NOTE: Up to two prior VEGFR-targeting TKI agents are allowed including, but not limited to lenvatinib and sorafenib\n* Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1·1 on chest CT (computed tomography)\u002Fabdominal\u002Fpelvis CT\u002FMRI (magnetic resonance imaging) performed within 4 weeks prior to randomization\n* Patient must have radiographic progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 over any time interval on or after most recent prior systemic treatment\n* Patient must not have any of the following cardiovascular and thromboembolic disorders or medical conditions:\n\n  * Congestive heart failure class 3 or 4 as defined by the New York Heart Association, unstable angina pectoris, or serious cardiac arrhythmias.\n  * Uncontrolled hypertension defined as sustained blood pressure \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment.\n  * Stroke, myocardial infarction, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months prior to randomization. Patients with more recent diagnosis of deep venous thrombosis are allowed if stable and treated with therapeutic anticoagulation for at least 6 weeks prior to randomization\n* Patient must not have any clinically significant hematemesis or haemoptysis of \\> 0·5 teaspoon (\\> 2·5 mL) of red blood or history of other significant bleeding within 3 months prior to randomization\n* Patient must not have any cavitating pulmonary lesion(s) or lesions invading major pulmonary blood vessels\n* Patient must not be on any concomitant anticoagulation with oral anticoagulants or platelet inhibitors, except for the following allowed agents:\n\n  * Low-dose aspirin for cardioprotection.\n  * Therapeutic anticoagulation with any agent in patients (1) without known brain metastases, (2) on a stable dose for at least 6 weeks prior to randomization, and (3) with no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Patient must not have any gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation:\n\n  * Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction\n  * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months prior to randomization\n* Patient must have completed any prior local therapy (e.g., surgery, radiation, ablation) at least 4 weeks prior to randomization, with complete wound healing and resolution of clinically relevant complications from prior local therapy\n* Patient must not have had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major surgery must have occurred 4 weeks prior to randomization and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days prior to randomization\n* Patient must not have any lesion(s) with ≥ 2cm growth within 3 months or ≥ 1.5cm growth within 2 months prior to randomization, and must not have documented anaplastic histology at or following cancer recurrence\n* Patient must not have had prior treatment with cabozantinib or any prior BRAF targeted therapy for thyroid cancer\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n\nAll patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.\n\nA patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 2 weeks after the last dose of dabrafenib and 4 months after the last dose of trametinib or cabozantinib. Patients must also not breastfeed while on study treatment and for 2 weeks after the last dose of dabrafenib and for 4 months after the last dose of trametinib or cabozantinib.\n\n  * NOTE: Patients of childbearing potential who are on hormonal contraceptives may be at risks because dabrafenib may decrease the efficacy of hormonal contraceptives. An effective non-hormonal contraception should be used during therapy and for 2 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib and cabozantinib\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Hemoglobulin (Hgb) ≥ 8 g\u002FdL obtained ≤ 28 days prior to protocol randomization\n* Leukocytes ≥ 3,000\u002FmcL obtained ≤ 28 days prior to protocol randomization\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL obtained ≤ 28 days prior to protocol randomization\n* Platelets ≥ 100,000\u002FmcL obtained ≤ 28 days prior to protocol randomization\n* Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) obtained ≤ 28 days prior to protocol randomization\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 × institutional ULN or \\\u003C 5.0 x ULN with the presence of hepatic metastasis obtained ≤ 28 days prior to protocol randomization\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m² obtained ≤ 28 days prior to protocol randomization\n* Urine protein\u002Fcreatinine (UPC) ratio ≥ 1 obtained ≤ 28 days prior to protocol randomization\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\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. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging obtained after central nervous system (CNS)-directed therapy (radiotherapy and\u002For surgery) shows no evidence of progression. CNS disease must be stable for at least 4 weeks prior to randomization; patients must be neurologically asymptomatic and without corticosteroid treatment at time of randomization\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 must have corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 500 ms obtained within 28 days prior to randomization.\n\n  * NOTE: If a single electrocardiogram (ECG) shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 minutes (min) must be performed within 30 min after the initial ECG, and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* Patient must be English or Spanish speaking to be eligible for the quality of life (QOL) component of the study.\n\n  * NOTE: Sites cannot translate the associated QOL forms",{"count":57,"type":21},264,[25],"This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and\u002For more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.",[61],"Refractory Differentiated Thyroid Gland Carcinoma",{"date":63,"type":40},"2026-06-18",{"date":65,"type":40},"2024-08-22",{"date":67,"type":21},"2030-09-30",{"name":46,"class":47},301,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100540606","phase-2-identifying-findings-on-brain-scans-that-could-help-make-better-predictions-about-brain-cancer-progression-the-gable-trial-100540606","NCT06319027","Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial","Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)","GABLE","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age.\n* Patient must have a Karnofsky Performance Status ≥ 60%.\n* Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria.\n* Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma.\n* Patient must have completed an MRI prior to the diagnostic surgery for GBM and have images available for upload into Transfer of Images and Data (TRIAD).\n* Patient must have diagnostic surgery for GBM within 7 weeks prior to registration.\n* Patient must have O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status ordered at time of registration.\n* Patient must have a post-operative (op) MRI completed within 3 weeks after diagnostic surgery for GBM and have images available for upload into TRIAD.\n* Patient must have no contraindications to MRI, including injection of gadolinium-based contrast agents, and demonstrated ability to tolerate MRI on pre-surgical imaging.\n* Patient must have no allergies to agents that may potentially be used for non-standard of care imaging (18F-fluciclovine, MR contrast).\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the interventions being used.\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\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.",{"count":79,"type":21},100,[24],"This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and\u002For magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor.",[83],"Glioblastoma, IDH-Wildtype",{"date":63,"type":40},{"date":86,"type":40},"2024-04-11",{"date":88,"type":21},"2027-05-31",{"name":46,"class":47},12,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100538786","cost-communication-and-financial-navigation-in-cancer-patients-costcom-100538786","NCT06295367","Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)","Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients","Inclusion Criteria:\n\n* NON-PATIENTS PARTICIPANTS: Participant must speak English\n* NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months\n* NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to participate in this study\n* NON-PATIENTS PARTICIPANTS: Participant must be one of the following:\n\n  * A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform\n  * A practice oncology provider (i.e., physician or mid-level), or\n  * A practice financial counselor, social workers, financial navigators, or pharmacist who have provided care or been in contact (in the last 3 months) to a patient who was assigned to the CostCOM arm, and who completed the at least 6 month study follow-up\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be ≥ 18 years of age\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be within 120 days of a new diagnosis of any solid cancer of any stage at the time of Step 0\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of Step 0\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not have indolent cancer undergoing observation alone (i.e., active surveillance)\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy), unless they are receiving systemic therapy\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have the ability to understand and the willingness to sign a written informed consent document.\n\n  * Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available are not eligible\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3, OR\n\n  * Patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials.\n\n  * NOTE: If S1912CD is activated in a participating practice, S1912CD should be offered first to patients with metastatic cancer meeting eligibility criteria for S1912CD. Only if a patient is not eligible or not interested in participating in S1912CD, the EAQ222CD can be offered. For early stage cancer, EAQ222CD can be offered first given S1912CD does not enroll patients with early stage cancer\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in other clinical trials where OOPC communication or financial navigation (i.e., professional guidance to identify financial assistance programs to alleviate cost of care) is being offered as part of the trial\n\n  * NOTE: If a trial is offering financial counseling alone without financial navigation patients are allowed to co-enroll\n  * NOTE: Gift cards for survey completion, or parking passes are not considered financial navigation\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have a completed baseline survey in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0)\n* PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy) either before or within 30 days of the date of OPEN registration and consent (step 0)",true,{"count":100,"type":21},760,[102],"NA","This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer.",[105],"Malignant Solid Neoplasm",{"date":63,"type":40},{"date":108,"type":40},"2024-02-29",{"date":110,"type":21},"2027-12-01",{"name":46,"class":47},392,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":98,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100524736","mobile-health-for-adherence-in-breast-cancer-patients-100524736","NCT06112613","Mobile Health for Adherence in Breast Cancer Patients","Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)","Inclusion Criteria:\n\n* NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)\n* NON-PATIENT: Participants must have taken care of at least one patient randomized to Arm B (CONCURxP) who had less than 85% adherence rate at 12 months as measured by the WiseBag\n* NON-PATIENT: Participant must speak English\n* NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months\n* NON-PATIENT: Participant must be able to provide informed consent to participate in this study\n* PATIENT STEP 0: Patient must be \\>= 18 years of age\n* PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish\n* PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0\n* PATIENT STEP 0: Patient must have initiated any of the CKD4\u002F6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent\n\n  * NOTE: Patients who have been treated previously with anticancer treatments other than CDK4\u002F6 inhibitors are eligible\n  * NOTE: CDK4\u002F6 inhibitors must be provided\u002Fsupplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible\n  * NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4\u002F6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered palbociclib can be determined based on the prescription order\n* PATIENT STEP 0: Patients must not have been previously treated with any of the following CDK4\u002F6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio\n* PATIENT STEP 0: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4\u002F6 inhibitors\n* PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at an NCORP site\n* PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages\n\n  * NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence\n* PATIENT STEP 0: Patient must have an email address\n\n  * NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to improve adherence\n* PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document\n\n  * NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available are not eligible\n* PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \\>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)\n* PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance\n\n  * NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance\n* PATIENT STEP 1: Patient must meet all the eligibility criteria for Step 0\n* PATIENT STEP 1: Patient must have signed a written informed consent form\n* PATIENT STEP 1: Patient must have completed baseline survey within 30 days of the date of Step 0 Registration\n* PATIENT STEP 1: Patients must have initiated their CDK 4\u002F6 inhibitors within 30 days of the date of Step 0 registration",{"count":121,"type":21},410,[102],"This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4\u002F6 inhibitor. To ensure CDK4\u002F6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4\u002F6 inhibitor.",[125,126,127,128],"Anatomic Stage IV Breast Cancer AJCC v8","Breast Carcinoma","HER2-Negative Breast Carcinoma","Hormone Receptor-Positive Breast Carcinoma",{"date":63,"type":40},{"date":131,"type":40},"2024-01-26",{"date":133,"type":21},"2027-07-31",{"name":46,"class":47},506,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100516308","evaluating-the-impact-of-social-and-genetic-factors-on-outcomes-in-adolescent-and-young-adult-cancer-survivors-100516308","NCT06002828","Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors","Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age at the time of registration\n* Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)\n* Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration\n* Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma must have been within one year prior to registration\n\n  * NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3\n* Patient must be English speaking in order to be able to complete the required QOL forms on this study\n\n  * NOTE: Sites cannot translate the associated QOL forms\n* Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma\n* Patient must have internet access through computer, tablet, or smartphone\n* Patient must have email address\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible",{"count":144,"type":21},2000,"OBSERVATIONAL","This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood samples and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors.",[148,149],"Hodgkin Lymphoma","Non-Hodgkin Lymphoma",{"date":63,"type":40},{"date":152,"type":40},"2023-10-13",{"date":154,"type":21},"2030-02-01",{"name":46,"class":47},428,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100505577","phase-3-testing-pump-chemotherapy-in-addition-to-standard-of-care-chemotherapy-versus-standard-of-care-chemotherapy-alone-for-patients-with-unresectable-colorectal-liver-metastases-the-pump-trial-100505577","NCT05863195","Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial","A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age\n* Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).\n\n  * Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).\n\n    * NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.\n  * Patient may have calcified pulmonary nodules, and\u002For =\\\u003C 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =\\\u003C 6 mm in maximal axial dimension.\n  * Patient's primary tumor may be in place.\n* Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer.\n\n  * NOTE: First-line chemotherapy may have included any of the following regimens as listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan (FOLFIRI) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI), each with or without any of the following: bevacizumab, cetuximab, or panitumumab.\n* Patient must have stable or responding disease on first-line chemotherapy by RECIST 1.1 criteria\n* Patient must meet the following criteria for technical unresectability:\n\n  * A margin-negative resection requires resection of three hepatic veins, both portal veins, or the retrohepatic vena cava OR a resection that leaves less than two adequately perfused and drained segments.\n  * NOTE: Institutional multidisciplinary review is required to confirm unresectability and rule out radiographically positive extrahepatic disease.\n* Patient must undergo CT angiography (chest\u002Fabdomen\u002Fpelvis) to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks prior to randomization.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and be clinically fit to undergo surgery as determined by the pre-operative evaluation.\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Total Bilirubin =\\\u003C 1.5 mg\u002FdL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional upper limit of normal (ULN) (obtained =\\\u003C 14 days prior to protocol randomization)\n* Creatinine =\\\u003C 1.5 x institutional ULN OR creatinine clearance \\>= 50 mL\u002Fmin calculated by the Cockcroft-Gault method (obtained =\\\u003C 14 days prior to protocol randomization)\n* Calcium \\>= institutional lower limit of normal (LLN)\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* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study\n\nExclusion Criteria:\n\n* Patient must not have a liver tumor burden exceeding 70% of total liver volume.\n* Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).\n* Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).\n* Patient must not have had prior treatment with HAI\u002Ffloxuridine (FUDR)\n* Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.\n* Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS).\n* Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture.\n* Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial.\n* Patient must not have cirrhosis and\u002For clinical or radiographic evidence of portal hypertension\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study.",{"count":165,"type":21},408,[25],"This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.",[169,170,171,172],"Metastatic Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Liver","Stage IV Colorectal Cancer AJCC v8","Unresectable Colorectal Carcinoma",{"date":63,"type":40},{"date":175,"type":40},"2023-10-19",{"date":177,"type":21},"2034-06-30",{"name":46,"class":47},60,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100405971","phase-3-testing-the-use-of-combination-therapy-in-adult-patients-with-newly-diagnosed-multiple-myeloma-the-equate-trial-100405971","NCT04566328","Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial","Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation","Inclusion Criteria:\n\n* STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)\n* STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria\n* STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS\n* STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.\n\n  * NOTE: Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay\n  * NOTE: Adaptive Biotechnologies will release results to the diagnostic Portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution\n* STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement\n* STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified\n* STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II\n\n  * NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and\u002For t(14;16) is considered high risk and absence of these, including any other findings, are standard risk\n  * R-ISS stage\n\n    * Stage I: ISS stage I \\[beta2 macroglobulin \\\u003C 3.5 mg\u002FL, albumin \\> 3.5 g\u002FdL\\] AND standard-risk CA AND normal LDH\n    * Stage II: Not R-ISS stage I or III\n    * Stage III: ISS stage III \\[beta2 macroglobulin \\> 5.5 mg\u002FL\\] AND high-risk CA OR high LDH (\\> upper limit of normal) \\[patients with stage III are ineligible\\]\n* STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:\n\n  * \\>= 1 g\u002FdL monoclonal protein (M-protein) on serum protein electrophoresis\n  * \\>= 200 mg\u002F24 hours of monoclonal protein on a 24-hour urine protein electrophoresis\n  * Involved free light chain \\>= 10 mg\u002FdL or \\>= 100 mg\u002FL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\\\u003C 0.26 or \\> 1.65)\n  * Monoclonal bone marrow plasmacytosis \\>= 30% (evaluable disease)\n* STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and\u002For aspirate is required within 28 days if bone marrow is being followed for response\n\n  * NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is \\>= 200 mg\u002F24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response\n  * NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike \\>= 1 g\u002FdL. Measurable disease in the urine is defined as having a urine M-spike \\>= 200 mg\u002F24 hr\n* STEP 1 - Calculated creatinine clearance \\> 30 mL\u002Fmin (obtained =\\\u003C 14 days prior to Step 1 registration)\n* STEP 1 - Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to Step 1 registration)\n* STEP 1 - Untransfused platelet count \\>= 75,000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to Step 1 registration)\n* STEP 1 - Hemoglobin \\>= 8.0 g\u002FdL (obtained =\\\u003C 14 days prior to Step 1 registration)\n* STEP 1 - Total bilirubin =\\\u003C 1.5 x ULN (institutional upper limit of normal) (obtained =\\\u003C 14 days prior to Step 1 registration)\n* STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 14 days prior to Step 1 registration)\n* STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration\n* STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\n* STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 1 - Patients with a history of hepatitis C virus (HCV) infection 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* STEP 1 - 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* STEP 1 - 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. Patients must not have evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration\n* STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation\n* STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be \\> 50% of predicted normal\n* STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies\n* STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression\n* STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle\n* STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)\n* STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less\n* STEP 2 - Hemoglobin \\>= 8 g\u002FdL (obtained within 14 days prior to Step 2 randomization)\n* STEP 2 - Platelet count \\>= 50,000\u002Fmm\\^3 (obtained within 14 days prior to Step 2 randomization)\n* STEP 2 - Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained within 14 days prior to Step 2 randomization)\n* STEP 2 - Calculated creatinine clearance \\>= 30 mL\u002Fmin (obtained within 14 days prior to Step 2 randomization)\n* STEP 2 - Total bilirubin =\\\u003C 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization)\n* STEP 2 - ALT and AST \\\u003C 3 x ULN (obtained within 14 days prior to Step 2 randomization)\n\nExclusion Criteria:\n\n* STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products\n* STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\n\n  * Has achieved menarche at some point,\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* STEP 1 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment\n* STEP 1 - Patient must not have peripheral neuropathy \\>= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration\n* STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification\n\n  * NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register\n* STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol\n\n  * NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment\n* STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant\n* STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\n\n  * Has achieved menarche at some point,\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* STEP 2 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception).\n\nMen must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment",{"count":188,"type":21},1450,[25],"This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.",[192,193,194],"Plasma Cell Myeloma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma",{"date":63,"type":40},{"date":197,"type":40},"2021-02-24",{"date":199,"type":21},"2027-12-31",{"name":46,"class":47},649,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":209,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100394987","phase-3-treating-prostate-cancer-that-has-come-back-after-surgery-with-apalutamide-and-targeted-radiation-based-on-pet-imaging-100394987","NCT04423211","Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)","Inclusion Criteria:\n\n* STEP 0: REGISTRATION ELIGIBILITY CRITERIA\n* Patient must be male and \\>= 18 years of age.\n* Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma\n* Patient must have biochemical recurrence (BCR) after RP, defined as follows:\n\n  * If time to BCR, defined as time to first detectable PSA ( \\> lower limit of normal for assay used) after RP, is \\\u003C 12 months, a minimum PSA level of \\>= 0.2 ng\u002FmL and a confirmatory reading of \\>= 0.2 ng\u002FmL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng\u002FmL are eligible)\n  * If time to BCR, defined as time to first detectable PSA (\\> lower limit of normal for assay used) after RP, is \\>= 12 months, a minimum absolute PSA of 0.5 ng\u002FmL is required\n  * If the patient has a detectable PSA (\\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement\n* Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen\u002Fpelvis or MRI abdomen\u002Fpelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET\u002FCT or PET\u002FMR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT\u002FMRI for soft tissue lesions and\u002For a bone scan for osseous lesions\n\n  * Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration\n* Extra-pelvic metastases is defined as any osseous metastases and\u002For any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET\u002FCT or PET\u002FMR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration\n* Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET\u002FCT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.\n* Patient must not be enrolled in another therapeutic clinical trial\n* Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery\n* Patients undergoing a PET\u002FMR must meet local institutional safety guidelines for MRI\n* Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration\n* Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy\n* Hemoglobin (Hgb) \\>= 9.0 g\u002FdL (independent of transfusion and\u002For growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)\n* Leukocytes \\>= 3,000\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Platelets \\>= 100,000\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, must have a direct bilirubin of \\\u003C 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)\n* Creatine \\\u003C 1.5 x instituional ULN (or measured creatinine clearance \\> 30 mL\u002Fmin)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\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 I or II (by patient symptoms) or A or B (by objective assessment)\n* Patient must not have completed a course of prior pelvic radiation therapy for any reason\n* Patient must agree not to father children while on study\n* Patient must be English or Spanish speaking to be eligible for the QOL component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms\n* STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA\n* Patient must have completed a baseline SOC PET\u002FCT or PET\u002FMR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration\n* For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)\n* For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \\[prostate bed +\u002F- typical whole pelvis\\]), the number of extra-pelvic lesions must be known (1 - 5 or \\> 5 extra-pelvic lesions)","MALE",{"count":211,"type":21},804,[25],"This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \\[PSA\\] after surgical removal of the prostate cancer).\n\nA second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.\n\nDiagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.",[215,216,217,218],"Biochemically Recurrent Prostate Carcinoma","Metastatic Prostate Carcinoma","Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8",{"date":63,"type":40},{"date":221,"type":40},"2020-10-08",{"date":223,"type":21},"2032-12-31",{"name":46,"class":47},342,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},"100380898","comparing-the-clinical-impact-of-pancreatic-cyst-surveillance-programs-and-associated-biomarkers-100380898","NCT04239573","Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers","Inclusion Criteria:\n\n* Patient must be ≥ 50 years and ≤ 75 years of age\n* Patient must not have acute pancreatitis or a history of chronic pancreatitis\n* Patient must have received a CT, MRI, or EUS within 6 months prior to enrollment that revealed one or more ≥ 1 cm pancreatic cyst(s).\n* Patients of childbearing potential must not be known to be pregnant\n* Patient must not have a prior diagnosis of pancreatic malignancy of any type\n* Patient must not have a history of pancreatic resection\n* Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible\n* Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children)\n* Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥ 10mm, cyst causing obstructive jaundice)\n* Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection\n* Patient must not be in any form of pancreatic cyst surveillance for \\> 1 year, defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must be ≥ 50 years and ≤ 75 years of age\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must not have acute pancreatitis or a history of chronic pancreatitis.\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patients of childbearing potential must not be known to be pregnant.\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must not have a prior diagnosis of pancreatic malignancy of any type.\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must not have a history of pancreatic resection.\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible.\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children).\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥10mm, cyst causing obstructive jaundice).\n* PRIOR TO ADDENDUM #5 08\u002F13\u002F2024: Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection.","50 Years","75 Years",{"count":235,"type":21},770,"The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.",[238],"Pancreatic Neoplasm",{"date":39,"type":40},{"date":241,"type":40},"2020-06-16",{"date":243,"type":21},"2031-12-31",{"name":46,"class":47},424,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},"100357713","phase-3-lenalidomide-and-dexamethasone-with-or-without-daratumumab-in-treating-patients-with-high-risk-smoldering-myeloma-100357713","NCT03937635","Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma","Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)","Inclusion Criteria:\n\n* Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:\n\n  * Abnormal serum free light chain ratio of involved to uninvolved \\>20, but less than 100 if the involved FLC is \\>= 10 mg\u002FdL by serum free light chain (FLC) assay\n  * Serum M-protein level \\>= 2 gm\u002FdL\n  * Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.\n  * \\>20% plasma cells on biopsy or aspirate\n* Bone marrow aspirate and\u002For biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.\n* \\>= 1 g\u002FdL on serum protein electrophoresis (within 28 days prior to randomization).\n* \\>= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization).\n\n  * NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted.\n* SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization.\n\n  * NOTE: UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is \\>= 200 mg\u002F24 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.\n* Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., \\> 11 mg\u002FdL or 1mg\u002FdL above upper limit of normal \\[ULN\\]).\n* Hemoglobin \\>= 11 g\u002FdL (within 28 days prior to randomization).\n* Platelet count \\>= 100,000 cells\u002Fmm\\^3 (within 28 days prior to randomization).\n* Absolute neutrophil count \\>= 1500 cells\u002Fmm\\^3 (within 28 days prior to randomization).\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin (within 28 days prior to randomization).\n* Bilirubin =\\\u003C 1.5 mg\u002FdL (within 28 days prior to randomization).\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) =\\\u003C 2.5 times the upper limit of normal (within 28 days prior to randomization).\n* Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis\u002Faspirin.\n* Patients must not have more than one focal marrow lesion on magnetic resonance imaging (MRI) of either pelvis or spine. Patients with indwelling pacemakers and\u002For ICD (implantable cardioverter-defibrillator) that is known or suspected to be MRI incompatible will be excused from this test.\n* Concurrent use of erythropoietin is not allowed while on study therapy.\n* Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted. Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.\n* Patients must not have active, uncontrolled seizure disorder. Patients must not have had a seizure in the last 6 months.\n* Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n* Patients with monoclonal gammopathy of undetermined significance are not eligible.\n* Patients must not have grade 2 or higher peripheral neuropathy per CTCAE.\n* Patients must not have active, uncontrolled infection.\n* Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.\n* Patients should not have New York Heart Association classification III or IV heart failure at baseline.\n* Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer. For most diseases this time frame is 5 years.\n* Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of REMS.\n* Women must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.\n* Human immunodeficiency virus (HIV)+ patients with undetectable HIV viral loads tested within 6 months are eligible.\n* Patients should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.\n* Patients must not have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization",{"count":254,"type":21},288,[25],"This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.",[258],"Smoldering Plasma Cell Myeloma",{"date":63,"type":40},{"date":261,"type":40},"2019-09-16",{"date":263,"type":21},"2029-12-31",{"name":46,"class":47},747,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100323628","phase-2-chemotherapy-before-surgery-and-radiation-therapy-or-surgery-and-radiation-therapy-alone-in-treating-patients-with-nasal-and-paranasal-sinus-cancer-that-can-be-removed-by-surgery-100323628","NCT03493425","Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery","Phase II Randomized Trial of Neo-Adjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* General physical condition compatible with the proposed chemotherapy and surgery\n* Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection:\n\n  * Stages T3 and T4a disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection\n  * The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neo-adjuvant chemotherapy for patients on Arm B\n\n    * Resection of skull base will be deemed necessary according to skull base bone erosion by CT or marrow involvement by MRI is noted; for any disease abutting the skull base; or for ethmoid sinus or frontal sinus involvement\n    * Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging\n* Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization\n* Patients may not be receiving investigational agents at time of registration, or at any time while on study and during the 4 weeks preceding enrollment\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel and\u002For both platinum-based chemotherapy agents are excluded; patient must be able to receive at least one of the two proposed chemotherapy regimens\n* Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded\n* Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors\n* Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded\n* Patients with a history of a different malignancy are excluded, unless the disease has not progressed for \\>= 2 years\n* Absolute neutrophil count (ANC) \\> 1500\u002Fmm\\^3 =\\\u003C 2 weeks prior to randomization\n* Hemoglobin (Hgb) \\> 8.0 g\u002FdL =\\\u003C 2 weeks prior to randomization\n* Platelet count \\> 100,000\u002Fmm\\^3 =\\\u003C 2 weeks prior to randomization\n* Creatinine clearance of \\> 60 ml\u002Fmin; creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockroft-Gault formula =\\\u003C 2 weeks prior to randomization\n* Total bilirubin within normal limits (must be obtained =\\\u003C 2 weeks prior to randomization)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the range allowing for eligibility, must be obtained \\\u003C 2 weeks prior to randomization\n* Alkaline phosphatase must be within the range allowing for eligibility, must be obtained \\\u003C 2 weeks prior to randomization\n* Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated\n* No current peripheral neuropathy \\> grade 2 at time of randomization\n* Patients must not have any co-existing condition that would preclude full compliance with the study; no prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n* Women must not be pregnant or breast-feeding\n\n  * All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy\n  * A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study\n* Patients must have measurable disease; MRI and\u002For PET\u002FCT scans need to be performed within 2 weeks prior to registration",{"count":274,"type":21},82,[24],"This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.",[278,279],"Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7","Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7",{"date":63,"type":40},{"date":282,"type":40},"2019-03-12",{"date":284,"type":21},"2029-03-31",{"name":46,"class":47},140,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":320},"100265421","phase-2-radiation-therapy-with-or-without-cisplatin-in-treating-patients-with-stage-iii-iva-squamous-cell-carcinoma-of-the-head-and-neck-who-have-undergone-surgery-100265421","NCT02734537","Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery","Phase II Randomized Trial of Radiotherapy With or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) With TP53 Sequencing","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0)\n* Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \\[NOS\\]) of the head\u002Fneck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer \\[AJCC\\] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0\n* Patient has undergone total resection of the primary tumor with curative intent\n\n  * NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days\n* For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)\n* Patients with, per the operative and\u002For pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and\u002For gross residual disease after surgery are not eligible\n* A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration\n\n  * NOTE: Complete the EA3132-specific FoundationOne requisition form\n* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and\u002For non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor\n* Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease\n* Patients with recurrent disease or multiple primaries are ineligible\n* RANDOMIZATION (STEP 1)\n* NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion\n* Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization\n* The patient must have the following assessments done =\\\u003C 8 weeks prior to randomization:\n\n  * Examination by a head and neck surgeon\n  * Chest x-ray (or chest computed tomography \\[CT\\] scan or CT\u002Fpositron emission tomography \\[PET\\] of the chest or magnetic resonance imaging \\[MRI\\]) to rule out distant metastatic disease\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization\n* Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3 within 4 weeks prior to randomization\n* Platelets \\>= 100,000\u002Fmm\\^3 within 4 weeks prior to randomization\n* Total bilirubin =\\\u003C the upper limit of normal (ULN) within 4 weeks prior to randomization\n* Calculated creatinine clearance must be \\> 60 ml\u002Fmin using the Cockcroft-Gault formula within 4 weeks prior to randomization\n* Patient must not have an intercurrent illness likely to interfere with protocol therapy",{"count":295,"type":21},189,[24],"This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.",[299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314],"Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant","Lip and Oral Cavity Squamous Cell Carcinoma","p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oral Cavity Verrucous Carcinoma","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 Oral Cavity Verrucous Carcinoma","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8",{"date":39,"type":40},{"date":317,"type":40},"2016-11-23",{"date":199,"type":21},{"name":46,"class":47},676,{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":328,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":358,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\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* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":331,"type":21},1582,[102],"This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Alveolar Soft Part Sarcoma","Angiosarcoma","Clear Cell Sarcoma of Soft Tissue","Dedifferentiated Liposarcoma","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Leiomyosarcoma","Malignant Peripheral Nerve Sheath Tumor","Myxofibrosarcoma","Pleomorphic Liposarcoma","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Sarcoma","Soft Tissue Sarcoma","Soft Tissue Sarcoma of the Trunk and Extremities","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Synovial Sarcoma","Undifferentiated Pleomorphic Sarcoma","NOT_YET_RECRUITING","2024-07-24",{"date":361,"type":40},"2024-07-30",{"date":363,"type":21},"2025-01-28",{"date":365,"type":21},"2032-11-01",{"name":46,"class":47},""]