[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fox Chase Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":651},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,44,81,106,127,146,167,187,209,239,265,297,325,351,373,394,425,446,473,494,520,541,566,588,616],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100644358","phase-2-mycophenolate-mofetil-w-prednisone-for-immune-related-hepatitis-from-checkpoint-inhibitor-therapy-100644358",false,"NCT07663422","Mycophenolate Mofetil w\u002F Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy","GU-228: Mycophenolate Mofetil in Combination With Prednisone as First-line Treatment of Immune Related Hepatitis Resulting From Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Patients must be ≥ 18 years at the time of irAE diagnosis and must have been diagnosed with a solid tumor or hematologic malignancy being treated with non-curative intent.\n* Patients must be diagnosed or presumed to have by a treating Medical Oncology or Hematology-Oncology clinician with immune-related hepatitis, G2-G3 (as defined in section 11.0), with plan for at least temporary interruption of IO therapy and initiation of corticosteroid treatment.\n* Patients must have been previously treated for any malignancy with at least one dose of an IO agent targeting the Programmed cell death protein 1 (PD-1)\u002Fprogrammed death-ligand 1 (PDL-1) or CTLA-4 axis. IO use may have occurred at any time prior to diagnosis of irAE.\n* Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must have been measured within screening window outlined in Section 8.0 (Study Calendar).\n* Patient must be able to take study medications by mouth.\n* Baseline hemoglobin (HgB) at time of enrollment ≥8.0 g\u002FdL, absolute neutrophil count (ANC) ≥ 1500\u002Fmm3, and platelet count ≥ 100,000\u002Fmm3 without red blood cell or platelet transfusion in the two weeks preceding measurement of lab values. Lab values are to be assessed within screening window outlined in Section 8.0 (Study Calendar).\n* Baseline estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2\n* Patients must be able to understand and willing to sign a written informed consent and HIPAA consent document.\n\nExclusion Criteria:\n\n* Patients previously treated for irAE hepatitis.\n* Patients diagnosed or presumed to have G4 immune-related hepatitis.\n* Patients receiving renal replacement therapy with hemodialysis or peritoneal dialysis at time of enrollment.\n* Patients with a documented history of Child-Turcotte-Pugh class B and C liver dysfunction.\n* Patients with significant liver dysfunction at time of presentation, as defined by an otherwise unexplained change in mental status or International Normalized Ratio (INR) ≥ 1.5 attributed to synthetic liver dysfunction.\n* Patients with active hepatitis B (HBV), hepatitis C (HCV), or tuberculosis. Confirmatory testing for these infections may be performed if no recent result is available in the patient's records and, in the opinion of the treating physician, such testing is clinically warranted. Past HBV is exclusionary. Patients with treated HCV infection and documented eradication are eligible to enroll.\n* Patients with uncontrolled human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus (HSV), or Varicella-zoster virus (VZV). Confirmatory testing for these infections is not required.\n* Patients with a history of gastrointestinal bleeding, ulceration, or perforations within one year of trial enrollment. Use of proton-pump inhibitor therapy is allowed.\n* Patients with any history of solid organ or allogeneic stem cell transplantation.\n* Patients with type I diabetes mellitus (DM).\n* Patients with type II DM with most recent glycated hemoglobin measurement greater than or equal to 9.0%.\n* Patients with a documented history of phosphoribosyl-transferase deficiency.\n* History of allergic reactions to MMF, prednisone, methylprednisolone, or dexamethasone.\n* Patients with decompensated congestive heart failure at time of enrollment, at the discretion of treating clinician, regardless of ejection fraction.\n* Patients with history of suicidal ideation or past suicide attempt.\n* Uncontrolled or intercurrent severe medical illness at the time of enrollment, as defined below:\n\n  1. Patients being treated with vasopressors\n  2. Patient requiring mechanical ventilation or extracorporeal membrane oxygenation\n  3. Patients being treated with parenteral antibiotic, antifungal, or antiviral medications\n* Patients with chronic autoimmune diseases requiring long-term immunosuppressive treatment at the time of enrollment, or for whom the mechanism of index inflammatory changes is too uncertain to initiate irAE-directed treatment at the discretion of treating provider.\n* Patients with congenital (e.g. combine variable immunodeficiency) or acquired (e.g. chronic leukemia) immunodeficiency requiring long-term prophylactic antimicrobial treatment at time of enrollment (e.g. intravenous immunoglobulin (IVIg), prophylactic antiviral treatment, etc.)\n* Women of child-bearing potential (WOCBP) who are pregnant or breast-feeding.\n* Patients unable to commit to use of reliable contraception throughout the study period.","ALL","18 Years",{"count":20,"type":21},31,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II study evaluates whether early treatment with mycophenolate mofetil (MMF) plus prednisone improves liver inflammation caused by immune checkpoint inhibitors. The study includes patients who develop moderate to severe immune-related hepatitis after receiving PD-(L)1 or CTLA-4-based cancer therapy. The main goal is to determine how many patients experience improvement in liver function within 30 days while successfully tapering steroids. Safety and treatment-related side effects will also be monitored.",[27,28],"Immune-mediated Hepatitis","Immune-related Adverse Event",[30,31,28],"irAE","Immune-mediated hepatitis","NOT_YET_RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":21},"2026-06-30",{"date":40,"type":21},"2028-09-30",{"name":42,"class":43},"Fox Chase Cancer Center","OTHER",{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100643245","prehabilitation-in-high-risk-oncologic-surgery-100643245","NCT07638410","Prehabilitation in High-risk Oncologic Surgery","SURG-236: Prehabilitation in High-risk Oncologic Surgery: A Prospective Cohort Study","Inclusion Criteria:\n\n* Evidence of probable or confirmed primary or recurrent malignant neoplasm of any stage\n* Planned to undergo neoadjuvant chemotherapy or chemoradiation\n* Eligible surgical candidate for one of the following procedures: pancreatectomy, gastrectomy, esophagectomy, cystectomy, low anterior resection, abdominoperineal resection, or cytoreductive surgery with heated intraperitoneal chemotherapy\n* Age greater than 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Ability to understand and willingness to sign a written informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization document\n\nExclusion Criteria:\n\n* Unable to complete study requirements, such as attending a minimum of two visits for each specialty referral. This will be assessed at the final preoperative visit, at which time the participant may be discontinued from the study and replaced. Participants will not be excluded due to lack of insurance coverage for health psychology visits.\n* Does not proceed to surgery at an affiliated institution\n* Pregnant or breastfeeding",{"count":52,"type":21},180,[54],"NA","The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally.\n\nThe main questions this study aims to answer are:\n\n1. Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery?\n2. Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery?\n3. Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment?\n\nParticipants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days.\n\nResearchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.",[57,58,59,60,61,62,63],"Pancreatic Cancer","Colo-rectal Cancer","Gastric Cancer","Esophageal Cancer","Bladder Cancer","Ovarian Cancer","Abdominal Surgery Complications",[65,66,67,68,69,70,71,72],"Prehabilitation","Preoperative Rehabilitation","Multimodal Prehabilitation","Major Abdominal Surgery","Oncologic Surgery","Neoadjuvant Therapy","Postoperative Complications","Cancer Surgery","2026-06-09",{"date":75,"type":36},"2026-06-11",{"date":77,"type":21},"2026-06-15",{"date":79,"type":21},"2030-03-15",{"name":42,"class":43},{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":88,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":105},"100585590","communication-about-sexual-health-in-gynecologic-cancer-100585590","NCT06904339","Communication About Sexual Health in Gynecologic Cancer","Promoting Effective Clinical Communication About Sexual Health After Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention","Inclusion Criteria:\n\n* At least 18 years old\n* Diagnosed with any stage (I-IV) gynecologic cancer\n* Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago\n* Attending visits in follow-up care at Fox Chase Cancer Center\n* Score of at least 3 on a sexual concerns screener question\n\nExclusion Criteria:\n\n* Not able to speak English\n* Not willing to have clinic visit audio recorded\n* Eastern Cooperative Oncology Group (ECOG) score \\> 2\n* Overt cognitive dysfunction or psychiatric disturbance","FEMALE",{"count":90,"type":21},200,[54],"The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.\n\nThe main questions it aims to answer are:\n\n1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?\n2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?\n\nResearchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care.\n\nParticipants will:\n\n1. Fill out a consent form and survey\n2. Have their next clinic visit audio recorded\n3. Fill out another survey right after their clinic visit\n4. Fill out a final survey 6 months after their clinic visit",[94],"Gynecologic Cancers",[96],"sexual health","RECRUITING","2026-05-29",{"date":100,"type":36},"2026-06-02",{"date":102,"type":36},"2025-02-20",{"date":40,"type":21},{"name":42,"class":43},1,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":105},"100500772","phase-2-iron-replacement-to-reduce-anemia-during-neoadjuvant-chemotherapy-100500772","NCT05800600","Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy","Iron-RANC","Inclusion Criteria:\n\n* Male or female patients \\> 18 years\n* Patients undergoing neoadjuvant chemotherapy, including radiation and\u002For immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.\n* Anemia defined as Hgb \\\u003C10.5 g\u002FdL during chemotherapy.\n* Iron storage levels of ferritin \\\u003C500 ng\u002FmL and iron saturation \\\u003C35%\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n\nExclusion Criteria:\n\n* Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb \\\u003C 11.0 g\u002FdL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new\u002Fexacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Prior parenteral iron infusion in the past 4 weeks\n* The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD\n* Concurrent systemic infection at the time of enrollment.\n* Known hypersensitivity to Iron sucrose\n* Pregnant or breast feeding. Refer to section 4.4 for further detail.\n* Anemia from another established etiology (i.e MDS, Myeloma)",{"count":114,"type":21},34,[24],"This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.",[118],"Anemia","2026-05-20",{"date":121,"type":36},"2026-05-22",{"date":123,"type":36},"2023-03-15",{"date":125,"type":21},"2028-02-01",{"name":42,"class":43},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":105},"100500770","phase-2-lymphoscintigraphy-directed-elective-neck-radiation-for-p16-favorable-risk-oropharynx-cancer-100500770","NCT05800574","Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer","A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation","Inclusion Criteria:\n\n* Pathologically confirmed squamous cell carcinoma of the oropharynx\n* Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below):\n* Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy\n* Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and\u002For by the treating radiation oncologist or a head and neck surgeon\n* CT with contrast and\u002For MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI\n* PET\u002FCT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy.\n* Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells.\n* Patients must provide their smoking history prior to registration. Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\\]\u002F20\n* Patients must have clinically and\u002For radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration\n* Age ≥ 18 years.\n* Adequate hematologic function within 14 days prior to registration\n* Adequate renal function within 14 days prior to registration\n* Adequate hepatic function within 14 days prior to registration\n\nExclusion Criteria:\n\n* Tumors that cross midline, regardless of T stage\n* N2 adenopathy (bilateral neck adenopathy)\n* Gross total excision of the primary site in a diagnostic procedure prior to either imaging and\u002For physical examination by registering physician.\n* p16-negative squamous cell carcinoma\n* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles\n* Prior systemic therapy for the study cancer\n* Prior head and neck cancer surgery that involved the neck (includes excisional biopsy)\n* Prior radiation therapy to the head and neck that would result in overlap of treated fields\n* History of allergic reaction attributed to Technetium-99m-tilmanocept used in lymphoscintigraphy\n* Uncontrolled intercurrent illness including, but not limited to, any other malignancy, other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breast feeding",{"count":135,"type":21},22,[24],"This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.",[139],"Oropharynx Cancer",{"date":121,"type":36},{"date":142,"type":36},"2023-03-14",{"date":144,"type":21},"2027-09-23",{"name":42,"class":43},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":105},"100500771","phase-2-dose-attenuated-chemotherapy-in-compromised-patients-with-lung-cancer-100500771","NCT05800587","Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer","Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and\u002For Comorbidities","Inclusion Criteria:\n\n* Must have histologically or cytologically confirmed stage IV (AJCC version 8) lung cancer (small cell or non-small cell). Patients with stage III disease who are not felt to be candidates for definitive therapy are also eligible.\n* Must fit into at least one of the subgroups of patients as defined in section 3.3.\n* Patients must have planned therapy with a regimen that includes at least one cytotoxic agent as listed in Table 1 (e.g. platinum, taxane, anti-metabolite, vinca alkaloid, podophylotoxin, camptothecin, lurbinectidin etc).\n* Must have measurable disease as per RECIST criteria 1.1.\n* History of treated or untreated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:\n* No ongoing requirement for corticosteroids as therapy for CNS disease\n* No stereotactic radiation or whole-brain radiation within 7 days prior to treatment initiation\n* Stable doses of anti-seizure medications are allowed if CNS disease has been treated and is stable. Treatment of CNS disease can include surgery, radiation or response to prior systemic therapy.\n* May have received prior therapy for lung cancer. There is no limit on the number of prior therapies.\n* Age \\> 18 years\n* ECOG performance status of 0-3\n* Ability to understand and willingness to sign a written informed and HIPAA consent documents.\n* Females of child-bearing potential must be willing to use an effective method of contraception for the course of the study through at least 6 months after the last dose of study medication.\n* Patients with known HIV infection and are receiving combination antiretroviral therapy with a viral load \\\u003C400 copies per mL at screening or CD4+ T-cell count \\> 350 cell per μL at screening and no history of AIDS-defining opportunistic infection \\\u003C 12 months before first dose of study drug are eligible.\n* Males who are fertile and who have partners who are Women of Child-bearing Potential (WOCBP) must agree to use effective method(s) of contraception as outlined in section 4.4 from the start of trial treatment, for the course of the study and 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Patients receiving only a targeted agent (e.g. TKI, sotorasib etc.) or immunotherapy without a cytotoxic agent.\n* Patients currently receiving investigational agents for cancer.\n* Patients with ECOG PS 3 and hepatic or renal dysfunction.\n* Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n* Undergone major surgery within 28 days prior to first dose of study treatment. The patient has elective or planned major surgery to be performed during the course of the clinical trial.\n* Have not recovered from adverse events due to anticancer agents administered previously except neuropathy, alopecia or endocrinopathies that can be treated with replacement therapy. Physician's discretion is allowed to decide which unresolved adverse events from previous therapy prohibit patient participation in this study.\n* Uncontrolled illness including, but not limited to, ongoing or active infection (other than chronic viral infections that are controlled, e.g. HIV, as described above), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (uncontrolled), cirrhosis, or psychiatric illness\u002F social situations that would limit compliance with the study requirements.\n* Patients with 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* Leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Indwelling catheters (e.g., PleurX®) are allowed.\n* Corrected serum Ca \\> 12 mg\u002Fdl.\n* Patients who are receiving hypocalcemic therapies (e.g. denosumab, bisphosphonates) who achieve appropriate serum calcium levels are eligible.\n* Pregnant or breast feeding.",{"count":154,"type":21},280,[24],"This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities.",[158,159,160],"Lung Cancer","Small-cell Lung Cancer","Non Small Cell Lung Cancer",{"date":121,"type":36},{"date":163,"type":36},"2023-02-22",{"date":165,"type":21},"2029-08-01",{"name":42,"class":43},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":105},"100477578","early-phase-1-study-of-cbl0137-in-combination-with-ipilimumab-and-nivolumab-therapy-in-melanoma-100477578","NCT05498792","Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma","MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma","Inclusion Criteria:\n\n1. Patients must have:\n\n   1. Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and\u002For surgery OR:\n   2. Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.\n   3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.\n2. Age \\> 18 years\n3. ECOG performance status 0 or 1\n4. Patients must have normal organ and marrow function\n\nExclusion Criteria:\n\n1. Patients may not be receiving any other investigational agents\n2. Patients with a known active autoimmune disease\n3. Prior treatment with CTLA-4 or PD1\u002FPD-L1 pathway targeted systemic treatment\n4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids\n5. Patients with ongoing diarrhea (\\> 4 bowel movements\u002Fday) unresolved despite medical and best supportive care in the two weeks preceding therapy",{"count":175,"type":21},12,[177],"EARLY_PHASE1","Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.",[180],"Locally Advanced or Metastatic Melanoma",{"date":121,"type":36},{"date":183,"type":36},"2022-11-30",{"date":185,"type":21},"2027-09-02",{"name":42,"class":43},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":105},"100459471","phase-2-trial-of-an-alternative-cabozantinib-dosing-schedule-in-metastatic-renal-cell-carcinoma-and-neuroendocrine-tumors-100459471","NCT05263050","Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors","GU-187: Phase II Trial of Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors","Inclusion Criteria\n\n* Cohorts A and B: Histologically or cytologically confirmed advanced RCC with any clear cell or non-clear cell component. 100% sarcomatoid is permissible.\n* Cohorts A and B: Patient may have had any number of prior therapies for Cohort A, but for Cohort B patients must not have received any systemic therapy in the metastatic setting\n* Patients who have received prior (neo)adjuvant immunotherapy with pembrolizumab or similar are eligible for Cohort B IF they completed the adjuvant therapy \\> 12 months from start of trial therapy\n* Treatment naïve patients may be treated in Cohort A if deemed not candidates for nivolumab or if felt single agent cabozantinib most appropriate by the treating clinician\n* Cohort C: Well differentiated NET, grades 1-3 (any primary site) who have progressed on or are not eligible for somatostatin analogs per treating physician discretion\n* Cohort C: Disease progression within prior 12 months\n* Cohort C: Prior or concurrent treatment with somatostatin analogue allowed but no limit on lines of therapy (stable dose of somatostatin for 2 months)\n\nAll Cohorts:\n\n* At least one measurable lesion as defined by RECIST version 1.1\n* No evidence of pre-existing uncontrolled hypertension as assessed by investigator. Patients may undergo adjustments or additions to their antihypertensive regimen before or during screening to achieve optimal BP control.\n* Age \\> 18 years.\n* ECOG performance status 0 - 2\n* Patients must have normal organ and marrow function as defined below\n\n  * Leukocytes, \\> 2,000\u002FmcL\n  * Absolute neutrophil count, \\> 1,500\u002FmcL\n  * Platelets, \\> 100,000\u002FmcL\n  * Hgb, \\> 9 g\u002FdL (\\>90 g\u002FL)\n  * Total bilirubin, ≤ 1.5 x ULN (with the exception of of individuals with Gilberts syndrome who may have a bilirubin \\<3.0 mg\u002FdL)\n  * AST\u002FALT (SGOT\u002FSGPT)\u002FALP, \\< 3 x ULN ALP ≤ 5x ULN with documented bone metastases.\n  * Albumin, \\> 2.8 g\u002FdL\n  * Creatinine clearance, \\> 30 Ml\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal\n  * PT\u002FINR or PTT, \\< 1.3 x the laboratory ULN\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment\n\nExclusion Criteria\n\n* Patients who have had systemic anti-cancer therapy or radiotherapy within 14 days or five half-lives, whichever is shorter, prior to entering the study.\n* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Ongoing clinically relevant complications from prior radiation therapy would preclude eligibility.\n* Patients with prior therapy with cabozantinib.\n* Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to Cohort B (treatment-naïve group).\n* Cohort B only: Active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* Cohort B only: Patients have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients may not be receiving any other investigational agents\n* History of allergic reactions or hypersensitivity attributed to compound of similar chemical or biologic composition to the agent(s) used in this study\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4 inhibitors and inducers. Refer to Section 5.3.2 for detailed information. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n* Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n* Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Cardiovascular disorders:\n* Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n* QTcF \\> 500 msec within 28 days before first dose of study treatment.\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 160 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.\n* Subjects with a diagnosis of incidental, sub-segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n* The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n* Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n\nNote: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n* Lesions invading or encasing any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible.",{"count":195,"type":21},111,[24],"This is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.",[199,200,201,202],"Metastatic Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma","Neuroendocrine Tumors","Carcinoid Tumor",{"date":121,"type":36},{"date":205,"type":36},"2022-01-21",{"date":207,"type":21},"2027-02",{"name":42,"class":43},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},"100627930","phase-1-neoadjuvant-cadi-05-in-combination-with-pembrolizumab-for-surgically-resectable-locally-advanced-head-and-neck-squamous-cell-carcinomas-100627930","NCT07455032","Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas","Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (LA-HNSCC)","Inclusion Criteria:\n\n* Histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx\u002Fhypopharynx\u002Foral cavity primaries (AJCC 8th edition) with programmed death ligand -1 (PD-L1) combined positive score (CPS) ≥ 1 (as determined by any clinical pathology laboratory) Patients must be planned for definitive surgical resection as determined by a multidisciplinary tumor board or equivalent multidisciplinary determination.\n* Patients with recurrence or metachronous primary SCC of head and neck origins with previous history of surgery\u002Fradio (chemo)-therapy are allowed if definitive surgery is planned and if pembrolizumab is planned as a neoadjuvant strategy. Patients should have recovered from the effects of radiation or other prior treatments: AE\u002Fsequelae should resolve to ≤ grade 2 (no minimum recovery period required).\n* Patients must have an archival biopsy from the primary tumor site or regional lymph nodal metastasis with adequate tumor tissue as judged by study PI. There should not be any oncological treatments between the pre-CADI-05 biopsy and W1 Pembrolizumab\u002FCADI-05 treatment initiation. Note: If pretreatment material is a cytology specimen and deemed unsuitable for correlative testing, a core biopsy will be strongly recommended.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Patients must consent to provide either archival (if available \\& sufficient) or fresh pre-treatment tissue biopsy for research, and consent for the use of their residual post-operative tissue for research.\n* Adequate bone marrow, liver and kidney function as demonstrated by:\n\n  * Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL\n  * Hgb \\> 7 g\u002FdL (use of transfusion to reach this threshold prior to study initiation is acceptable)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.5\n\n    * upper limit of normal (ULN)\n  * Total serum bilirubin ≤1.5 ULN\n  * Patients with suspected Gilbert's disease may enroll provided that total bilirubin must be \\\u003C 3 mg\u002FdL\n  * Creatinine clearance (CrCL) \\> 30 mL\u002Fmin as measured via Cockcroft-Gault\n* Female patients must be surgically sterile or be postmenopausal or must use highly effective contraception while receiving trial treatment.\n* Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.\n\nExclusion Criteria:\n\n* Patients who are considered candidates for organ preservation through upfront concurrent chemoradiation therapy will be excluded from this study.\n* Receiving any investigational agent currently or within 28 days of first dose of CADI-05.\n* Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the subject or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis, Crohn's disease\\]; diverticulitis with the exception of a prior episode that has resolved or diverticulosis; celiac disease; irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; rheumatoid arthritis; hypophysitis, uveitis; etc.) within the past 2 years prior to the start of treatment. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n* Other prior or concomitant malignancies with the exception of:\n\n  * Non-melanoma skin cancer\n  * In-situ malignancy or any other malignancy that does not affect the primary management of the HNSCC under consideration including delivery of neoadjuvant pembrolizumab and definitive surgery plan.\n  * Low-risk prostate cancer after curative therapy\n  * Other cancer for which the subject has been disease free for ≥ 2 years before the first dose of study drug and of low potential risk for recurrence.\n* Any concurrent chemotherapy, investigational treatment, biologic or hormonal therapy for cancer treatment except adjuvant intent hormonal therapy for definitively treated breast or prostate cancer that has not recurred in last 2 years. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.\n* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of CADI-05. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiological doses not to exceed 10mg\u002Fday of prednisone or equivalent. \\[NOTE: If systemic corticosteroids are part of the treatment regimen for the indication under study, the systemic corticosteroid is permitted\\].\n* Uncontrolled human immunodeficiency virus (HIV) infection with CD4+ T \\\u003C 200 cells\u002Fmm3.\n* Untreated or uncontrolled hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV). Patients with hepatitis B receiving treatment with anti- HBV therapy and having undetectable virus titers will be included.\n* History of primary immunodeficiency.\n* History of organ transplant.\n* Pregnant or breastfeeding. Refer to section 4.4 for further detail.",{"count":135,"type":21},[218],"PHASE1","The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), can help treat locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. It will also learn about the safety of drug CADI-05. The main questions it aims to answer are:\n\n* Does using CADI-05 together with pembrolizumab help the immune system fight cancer better and lead to better results for patients?\n* What side effects or health problems might happen when people receive these two treatments?\n\nParticipants will:\n\n* Get pembrolizumab by IV (through a vein) once on day 1 of week 1 and again day 1 of week 4. This is standard of care treatment.\n* Get CADI-05 as a small injection into the skin once a week for 5 weeks. This is the experimental (research) treatment.\n* Visit the clinic every week for treatments, checkups and tests for 5 weeks.\n* Have surgery between week 6 and week 7.\n* Return to the clinic once for a follow-up visit about 30 days after surgery.",[221],"Squamous Cell Carcinoma of Head and Neck",[223,224,225,226,227,228,229],"Squamous cell Carcinoma of Head and Neck","CADI-05","Pembrolizumab","Immunotherapy","Neoadjuvant","Surgery","Locally advanced","2026-04-10",{"date":232,"type":36},"2026-04-15",{"date":234,"type":36},"2026-04-08",{"date":236,"type":21},"2028-01-31",{"name":42,"class":43},2,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":105},"100610004","phase-2-pembrolizumab-maintenance-after-enfortumab-vedotin-evpembro-induction-in-front-line-metastatic-urothelial-carcinoma-100610004","NCT07221942","Pembrolizumab Maintenance After Enfortumab Vedotin (EV)\u002FPembro Induction in Front-Line Metastatic Urothelial Carcinoma","Pembrolizumab Maintenance After Enfortumab Vedotin\u002FPembrolizumab Induction in Front-Line Metastatic Urothelial Carcinoma","IMPROEV","Inclusion Criteria:\n\n* Patients must have histologically and radiographically confirmed locally advanced, unresectable urothelial carcinoma.\n* Patients should not have received prior systemic therapy for metastatic disease.\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1\n* Patients may have received prior neoadjuvant or adjuvant immune checkpoint inhibitor therapy for localized disease and are eligible if they completed the treatment ≥12 months prior to initiating treatment on this clinical trial.\n* ECOG performance status 0-2\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study. Formalin fixed, paraffin embedded (FFPE) tissue block(s) or at least 25 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.\n* Normal organ and marrow function as defined below.\n\n  * Absolute neutrophil count \\> 1,000\u002Fmm3 unless patient has constitutional neutropenia\n  * Platelets \\> 100,000\u002Fµl\n  * Hemoglobin \\> 8.0 g\u002FdL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 x upper limit of normal (ULN) or \\\u003C3.5 x ULN if liver metastases\n  * Creatinine Clearance \\>20 ml\u002Fmin\n\nExclusion Criteria:\n\n* Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.\n* Grade 2 or higher baseline sensory or motor neuropathy.\n* Uncontrolled diabetes (HbA1c \\>8%)\n* Patients with uncontrolled and untreated central nervous system (CNS) metastases.\n\n  * Prior radiation to CNS metastases is permitted.\n  * Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence.\n  * Patient should not have leptomeningeal disease\n  * CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.\n  * If requiring steroid treatment for CNS metastases, the patient is on stable dose \\\u003C 10 mg\u002Fday of prednisone or equivalent for at least 2 weeks prior to starting treatment\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would substantially impair the patient's ability to comply with study requirements. Efforts should be made to provide reasonable accommodations before determining exclusion based on social limitations.\n* Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment. Adjuvant hormonal therapy for breast cancer is allowed.\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.\n* Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with enfortumab vedotin.\n* History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Prior allogeneic stem cell or solid organ transplant.\n* Other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.\n* Patients with active tuberculosis.\n* Pregnant or breast feeding\n* History of autoimmune diseases. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n  * Patients with vitiligo or residual autoimmune hypothyroidism on stable doses of hormone replacement are permitted to enroll.\n  * Patients with type 1 diabetes mellitus (T1DM) on a stable dose of insulin are permitted to enroll.\n  * Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* On high dose steroids at the time of study enrollment, defined as \\>10 mg prednisone (or bioequivalent), including steroids used for management of intracranial lesions. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n* Patients who received prior immunotherapy for mUC or for an alternative malignancy are eligible unless they developed an immune related adverse event while on therapy requiring cessation of therapy or use of disease modifying agents, corticosteroids, or immunosuppressive drugs.",{"count":248,"type":21},97,[24],"This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled. Induction consists of EV (1.25 mg\u002Fkg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg\u002Fkg allowed) and P (200 mg IV on Day 1 of each cycle). Radiographic assessments occur after 3 and 6 cycles. Patients achieving complete or partial response transition to maintenance P (400 mg IV every 6 weeks or 200 mg IV every 3 weeks) for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for P. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients will enter long-term or survival follow-up as applicable.",[252,253,254],"Metastatic Urothelial Carcinoma","Unresectable Urothelial Carcinoma","Advanced Urothelial Carcinoma",[256],"Urothelial carcinoma","2026-02-17",{"date":259,"type":36},"2026-02-19",{"date":261,"type":36},"2026-01-23",{"date":263,"type":21},"2029-09-03",{"name":42,"class":43},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":273,"sex":17,"minAge":274,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":105},"100576229","care-study-cancer-asian-americans-and-relationship-enrichment-100576229","NCT06782581","CARE Study: Cancer, Asian Americans, and Relationship Enrichment","Positive Activities for Asian American Cancer Patients and Caregivers","CARE","Inclusion Criteria for Patients:\n\n1. self-identifies as Asian American or Asian\n2. males or females ages 21-80 years\n3. within 2 years of any cancer diagnosis or stage 4 cancer diagnosis\n4. actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,\n5. able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week\n6. able to read, write, and speak English (i.e., English proficient; EP) or Mandarin\u002Fsimplified Chinese.\n\nExclusion Criteria for patients:\n\n1. life expectancy less than 6 months in the opinion of the primary physician\n2. inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),\n3. major thought disorder (e.g., schizophrenia or bipolar \\[patient records or self-disclosure\\]).\n\nInclusion Criteria for Caregivers:\n\n1. identifies as Asian American or Asian,\n2. patient considers them to be caregiver\n3. English proficient or Mandarin Chinese proficient\n4. access to computer\u002Fphone, internet, and web browser.\n\nExclusion Criteria for Caregivers:\n\n1. unwilling or unable to participate in the study for any reason,\n2. under the age of 18.",true,"21 Years","80 Years",{"count":277,"type":21},186,[54],"The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.",[281],"Neoplasm",[283,284,285,286,287,288],"Asian American","Cancer","Patient","Positive Activities","Well-being","Caregiver","2025-12-29",{"date":291,"type":36},"2025-12-31",{"date":293,"type":36},"2024-08-06",{"date":295,"type":21},"2027-02-15",{"name":42,"class":43},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":105},"100609936","phase-1-adaptive-radiation-boost-for-rectal-cancer-100609936","NCT07221058","Adaptive Radiation Boost for Rectal Cancer","Adaptive Radiation BOost for Rectal Cancer: a Phase I Dose Escalation Study (ARBOR)","ARBOR","Inclusion Criteria:\n\n1. Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.\n2. Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.\n3. Subjects must be willing to undergo MRI scans.\n4. Age ≥18 years.\n5. ECOG performance status 0 or 1.\n6. Estimated survival of ≥ 12 months.\n7. Subjects must have normal organ and marrow function as defined below\n\n   * Absolute neutrophil count \\> =1,000\u002FmcL\n   * Platelets \\>= 75,000\u002FmcL\n   * Total bilirubin \\\u003C 3 mg\u002FdL\n8. Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.\n\n   * Before ART: Capecitabine at a dose of 825 mg\u002Fm²\n   * After ART: FOLFOX combination chemotherapy, or 5-FU, or capecitabine\n9. Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.\n\nExclusion Criteria:\n\n1. Subjects who have been previously treated for rectal cancer are excluded.\n2. Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)\n3. Subjects must not be receiving any other investigational agents.\n4. Subjects may not have had prior pelvic radiation.\n5. Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer.\n6. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s).\n8. Subjects must not be pregnant or breast-feeding.",{"count":306,"type":21},37,[218],"The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer.\n\nThe main questions the study aims to answer are:\n\n* Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue?\n* Can it reduce the side effects that people may experience during treatment?\n\nParticipants will:\n\n* First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine.\n* Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds.\n* Use a small balloon during treatment to help aim the radiation and protect healthy areas.\n* Finally, receive additional chemotherapy (such as FOLFOX) for four months.",[310],"Rectum Cancer, Adenocarcinoma",[312,313,314,315,316],"Adaptive Radiation Therapy","Rectum Cancer","Adenocarcinoma","Organ Preservation","Total Mesorectal Excision","2025-12-02",{"date":319,"type":36},"2025-12-09",{"date":321,"type":36},"2025-10-24",{"date":323,"type":21},"2029-11-01",{"name":42,"class":43},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":335,"phases":4,"briefSummary":336,"conditions":337,"keywords":341,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":238},"100546560","increasing-pre-surgical-identification-of-muscle-invasive-tumor-evaluations-prior-to-planned-cystectomy-insite-100546560","NCT06396533","Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)","Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy","INSITE","Inclusion Criteria:\n\n1. Properly counselled patients with high grade T1 disease who elect for cystectomy\n2. Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy\n3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy\n4. Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).\n5. Male or female patients age \\>=18 years at the time of consent.\n6. Able and willing to comply with study requirements.\n7. Patients must have a non-contrast phase component for CT scans of chest\u002Fabdomen\u002Fpelvis either pre-existing (prior to accrual) or obtained during the screening process.\n8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.\n9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.\n\nExclusion Criteria:\n\n1. Patients who undergo cystectomy with non-curative intent will be excluded.\n2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.\n3. Patients who are pregnant or nursing.",{"count":334,"type":21},92,"OBSERVATIONAL","This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.\n\nPatients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.",[338,339,340],"Urothelial Carcinoma","Muscle Invasive Bladder Urothelial Carcinoma","Non-Muscle Invasive Bladder Urothelial Carcinoma",[342],"cystectomy","2025-10-30",{"date":345,"type":36},"2025-10-31",{"date":347,"type":36},"2024-08-13",{"date":349,"type":21},"2029-02-23",{"name":42,"class":43},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":105},"100506921","phase-1-adaptive-radiation-for-abdominopelvic-metastases-100506921","NCT05880667","Adaptive Radiation for Abdominopelvic Metastases","Adaptive Radiation for Abdominopelvic Metastases (ARAM)","Inclusion Criteria:\n\n1. Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, IR techniques, or growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed.\n2. Age \\> 18 years.\n3. ECOG performance status 0 or 1\n4. Estimated survival of \\>\u002F= 12 months\n5. Subjects must have normal organ and marrow function as defined below\n\n   * Absolute neutrophil count \\> 1,500\u002FmcL\n   * Platelets \\> 100,000\u002FmcL\n   * Total bilirubin \\\u003C 2 mg\u002FdL\n   * AST\u002FALT (SGOT\u002FSGPT) \\\u003C 5X ULN\n   * Creatinine \\\u003C 1.5X ULN OR\n   * Creatinine clearance ≥ 50 ml\u002Fmin\u002F1.73 m2 for subjects with creatinine levels above institutional normal\n6. Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.\n\nExclusion Criteria:\n\n1. Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue.\n2. Subjects must not be receiving any other investigational agents.\n3. Subjects must not have known peritoneal carcinomatosis visible on imaging.\n4. Subjects must not have known active solid tumors on imaging outside of abdomen\u002Fpelvis noted on screening imaging\n5. Subjects must not have 6 or more active metastatic sites.\n6. Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.\n7. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n8. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).\n9. Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.",{"count":359,"type":21},30,[218],"Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled.",[363,364],"Neoplasm - Soft Tissue Pelvis Malignant Secondary","Malignant Neoplasm of Stomach","2025-10-28",{"date":367,"type":36},"2025-10-29",{"date":369,"type":36},"2023-08-01",{"date":371,"type":21},"2029-06-01",{"name":42,"class":43},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"100460317","phase-1-neratinib-and-fam-trastuzumab-deruxtecan-in-advanced-gastro-esophageal-cancer-patients-100460317","NCT05274048","Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients","A Multi-Center Phase I Trial of Neratinib and Fam-trastuzumab Deruxtecan in Advanced Refractory Gastric and Esophageal Cancer Patients","Inclusion Criteria:\n\n1. Patients must have been diagnosed with histologically or cytologically confirmed gastrointestinal cancer (esophagus, stomach, colon, biliary, pancreas or unknown primary likely GI), and been deemed unresectable or have at least one site of metastatic disease\n2. Patients must have evaluable or measurable disease by RECIST 1.1 criteria\n3. 4.1.3 Patients' tumors must have HER2-overexpressing:\n\n   1. (IHC 3+ or IHC2+\u002FISH+) advanced gastroesophageal cancer (including gastroesophageal junction adenocarcinoma).\n   2. IHC 3+ for other GI cancers\n4. Patients must have received at least one prior line of HER2 directed therapy for metastatic\u002Funresectable disease and completed treatment at least 2 weeks prior to C1D1 (only for Gastroesohageal cancers, not for other GI cancers)\n5. 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\n6. Age \\> 18 years.\n7. ECOG performance status 0-2\n8. Patients must have normal organ and marrow function as defined below\n\n   * Leukocytes \\> 3,000\u002FmcL\n   * Absolute neutrophil count \\> 1,500\u002FmcL\n   * Platelets \\> 90,000\u002FmcL\n   * Hemoglobin \\> 9 gm\u002Fdl\n   * Total bilirubin \\\u003C 2 times institutional normal limits\n   * AST\u002FALT (SGOT\u002FSGPT) \\\u003C 5 times institutional normal limits if liver metastases and \\\u003C\u002F+ 2 times institutional normal limits otherwise\n   * Creatinine \\\u003C 2.0mg\u002FdL OR\n   * Creatinine clearance \\> 50 Ml\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal\n9. Left Ventricular Ejection Fraction ≥ 45% or lower limit of normal.\n10. Chemotherapy is harmful to the human fetus. For this reason, females of childbearing potential must be willing to use an effective method of contraception, as outlined in Section 4.4, for the course of the study through at least 6 months after the last dose of study medication. Males who have women of childbearing (WOCB) partners must agree to use an effective method of contraception as outlined in Section 4.4 for the course of the study through 8 months after the last dose of study medication.\n11. Patients should be willing and able to swallow oral tablet medications\n12. Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n\nExclusion Criteria:\n\n1. Patients who have had chemotherapy, or radiotherapy within 2 weeks prior to C1D1 or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier (secondary hypothyroidism from prior immunotherapy is permissible if controlled on thyroid hormone replacement). Recovery is defined as any treatment onset adverse events returning to baseline or otherwise deemed not clinically significant.\n2. Patients may not be receiving any other investigational agents for advanced cancer and must not have received prior treatment with TDxD\n3. Immunotherapy and treatments involving any investigational agents must be discontinued for \\>21 days before Cycle 1 Day 1 (C1D1)\n4. Patients with known untreated brain metastases are excluded from this study because of their poor prognosis and frequent development of neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Treated brain metastases are allowed (requires stability on MRI at least 4 weeks after initial treatment). Patients with treated brain metastases are allowed to be treated with steroid and\u002For anti-convulsants if the dose remains stable or decreases over the last 4 weeks prior to C1D1\n5. Patients with ongoing diarrhea (\\> 4 bowel movements\u002Fday) unresolved despite medical and best supportive care in the two weeks preceding therapy\n6. Patients will be excluded if they have had interstitial lung disease or pneumonitis or were suspected to have interstitial lung disease or pneumonitis that could not be ruled out on imaging at screening or if they had a history of noninfectious interstitial lung disease or pneumonitis that had been treated with glucocorticoids. Similarly, patients with clinically significant lung disease requiring O2 support or impaired lung function per investigator should be excluded\n7. History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study\n8. Patients receiving any medications or substances that are strong inhibitors or inducers of Neratinib and\u002For TDxD are ineligible.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to \\>470 msec (female subjects) or \\>450 msec (male subjects) based on average of the Screening triplicate12-lead ECG.\n11. Any patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, including uncontrolled HIV with CD4 count \\\u003C200, untreated Hepatitis B are excluded from the study. Patients who have been treated for hepatitis C definitively with evidence of sustained virologic response, as well as HIV and hepatitis B patients on treatment with undetectable viral load will be eligible for inclusion.\n12. Pregnant or breast feeding.",{"count":381,"type":21},18,[218],"This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+\u002FISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.",[59,385,386],"Gastrointestinal Cancer","HER2 Gene Mutation",{"date":367,"type":36},{"date":389,"type":36},"2022-06-24",{"date":391,"type":21},"2027-06",{"name":42,"class":43},3,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":402,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":105},"100609801","adaptive-radiation-therapy-for-men-with-intermediate--or-high-risk-prostate-cancer-100609801","NCT07219303","Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer","Dose Escalated CT-Based Adaptive Stereotactic Body Radiation Therapy Among Patients With Intermediate- and Favorable High- Risk Prostate Cancer (DE-CART)","DE-CART","Inclusion Criteria:\n\n1. Subjects must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate.\n2. Age \\> 18 years.\n3. ECOG performance status ≤ 2\n4. Prostate volume (segmented) ≤ 100 cc determined by MRI and\u002For US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on prior ADT. A simulation MRI is acceptable.\n5. Subjects must have had a pre-treatment diagnostic multiparametric MRI prostate (mpMRI) showing a PI-RADS3, 4 or 5 lesion or a 68Ga- or 18F-PSMA (TLX591-CDx or piflufolastat F18) PET\u002FCT within 12 mo of study registration.\n6. Baseline International Prostate Symptom Score (IPSS) is ≤ 15. Baseline alpha blocker use is allowed.\n7. Subjects must have full capacity to understand and be willing to sign the informed consent document.\n\nExclusion Criteria:\n\n1. Subjects must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline.\n2. Subjects must not be receiving any other investigational agents.\n3. Subjects must not have had prior pelvic radiation therapy.\n4. Subjects must not have node-positive disease.\n5. Subjects must not have extraprostatic extension determined by MRI prostate within 24 mo of treatment. For patients receiving ADT, the prostate MRI must have been obtained prior to the start of ADT.\n6. Subjects must not have had prior ablative therapies for prostate cancer including cryosurgery, HIFU and nanoknife.\n7. Subjects with prior TURP or laser enucleation are eligible. However, patients that have undergone prior simple prostatectomy are excluded.\n8. Subjects that are receiving other antineoplastic agents including methotrexate are ineligible. Subjects that have received prior ADT are eligible if they have received \\\u003C 6 mo total of ADT, if last administration of ADT was \\> 6 mo prior to registration and serum total testosterone levels have recovered to at least 100 ng\u002FdL. Subjects with prior cancer diagnoses are eligible provided that treatment was completed and no evidence of disease status achieved at least 2 years prior to study registration.\n9. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).\n11. Subjects with active inflammatory bowel disease or active collagen vascular disorder.\n12. Subjects that cannot undergo prostate fiducial placement.\n13. Subjects that cannot undergo rectal spacer placement are excluded. Please, note that a rectal spacer incorporating iodine or similar CT contrast is preferred. However, patients that are able to only have a non-contrast rectal spacer due to iodine allergy or similar contraindication remain eligible.\n14. Subjects that cannot undergo prostate MRI.\n15. Subjects with bilateral prosthetic hips will be excluded. Subjects with unilateral prosthetic hips will be eligible only if the initial treatment plan meets all target and normal tissue constraints without protocol violation.","MALE",{"count":404,"type":21},80,[54],"The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time.\n\nThe main questions this trial aims to answer are:\n\n* What is highest dose of adaptive SBRT without causing serious side effects?\n* Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs?\n* What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment?\n* Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment?\n\nParticipants will:\n\n* Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks.\n* Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing.\n* Visit the clinic for check-ups and tests:\n\n  * At 90 days (about 3 months) after treatment\n  * Then every 3 months for the first year\n  * Then every 6 months after that",[408],"Prostate Cancer (Adenocarcinoma)",[410,411,412,413,414,415,314,416,417],"Adaptive","SBRT","Stereotactic body radiation therapy","QOL","Simultaneous integrated boost","SIB","Prostate Cancer","Prostate Neoplasms","2025-10-27",{"date":367,"type":36},{"date":421,"type":36},"2025-09-25",{"date":423,"type":21},"2033-11-01",{"name":42,"class":43},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":105},"100591756","adaptive-radiation-for-locally-advanced-unresectable-pancreatic-cancer-100591756","NCT06984562","Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer","Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer: Phase I Dose Escalation Study","Inclusion Criteria\n\n1. Patients must have histologically or cytologically-confirmed PDA.\n2. Patients must have locally advanced unresectable PDA.\n\n   • This includes the following- per NCCN criteria\\*: 2.1 Unreconstructible involvement with the superior mesenteric vein or portal vein due to tumor or bland thrombus OR 2.2 Solid tumor contact with greater than 180 degrees of the superior mesenteric artery or celiac artery OR 2.3. Solid tumor contact with the aorta OR 2.4. Patients with non-metastatic disease that is inoperable by virtue of the operation posing excessive risk to the patient\n\n   \\*All patients must have been reviewed in the multidisciplinary conference and determined to have unresectable disease by a pancreatic surgeon and to have received or be ineligible for induction chemotherapy based on medical oncology assessment. Documentation of this review in EPIC meeting minutes will satisfy this requirement.\n3. Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART.\n4. Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.\n5. Adequate bone marrow, hepatic, renal function:\n\n   * ANC ≥ 1,500\u002Fµl and PLT ≥ 100,000\u002Fµl\n   * Bilirubin less than 1.5 ULN\n   * AST and ALT \\\u003C 3X ULN\n   * Serum Creatinine \\\u003C1.5X ULN\n6. Women of childbearing potential must not be pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrheal and non-lactating for at least 12 months to be considered of non-childbearing potential. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence\u002Fcontraception) while on study and for at least 6 months after therapy is completed.\n7. Age ≥ 18 years\n8. Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment, tissue sample collections, and follow-up.\n\nExclusion Criteria\n\n1. Radiologically or cytologically confirmed metastatic disease.\n2. Patients who have had any prior radiation therapy for pancreatic cancer.\n3. Patients who have had prior chemoradiation to an overlapping volume.\n4. Patients with adenosquamous carcinoma of the pancreas.\n5. Subjects who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to \\\u003C Grade 2. Patients who received previous immunotherapy or other antibody therapy, within 28 days (immune related toxicities must have resolved to \\\u003C= Grade 2 prior to starting treatment). Study treatment may be started within these washout periods or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient.\n6. Concurrent non-study chemotherapy or biologic therapy.\n7. A history of ataxia telangiectasia or other documented history of radiation hypersensitivity.\n\n   • Includes both bi- and mono-allelic likely pathogenic or pathogenic ATM mutations (VUS is acceptable).\n8. Serious, active infections requiring treatment with IV antibiotics",{"count":433,"type":21},16,[54],"The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer.\n\nThe main questions the study aims to answer are:\n\n* Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the healthy tissue around the tumor?\n* Can ART help reduce the side effects that participants may experience during treatment?\n\nParticipants will:\n\n* Undergo CT scans to plan the exact location of the radiation treatment. During this process, 1-3 small markers may be placed in or near the tumor to help with the planning.\n* Have a tumor biopsy, which involves taking a small sample of tissue from the cancer.\n* Receive 5 radiation treatments every other day over a 2-week period.\n* Provide blood samples before, during, and after your radiation treatment.",[437],"Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)",[312,439,440],"Pancreatic Ductal Adenocarcinoma","Locally advanced unresectable PDA",{"date":367,"type":36},{"date":443,"type":36},"2025-08-20",{"date":165,"type":21},{"name":42,"class":43},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":460,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":105},"100605817","early-phase-1-neuroprotective-potential-of-cannabidiol-cbd-in-preventing-oxaliplatin-ox-induced-neuropathy-100605817","NCT07167446","Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy","Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study","Inclusion Criteria:\n\n1. Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).\n2. Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment.\n3. ECOG PS 0-2\n4. No prior platinum exposure\n5. No evidence of ongoing neuropathy of any grade at the time of enrollment\n6. Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below:\n\n   1. Total Bilirubin: less than and\u002For equal to 1.5 X ULN\n   2. AST(SGOT)\u002FALT(SGPT): less than and\u002For equal to 3 X ULN (5 X ULN in patients with liver metastases\n7. Ability to understand and willingness to sign a written informed consent and HIPAA consent document.\n\n   Exclusion Criteria:\n8. Family history of genetic\u002Ffamilial neuropathy and personal history of ongoing neuropathy (any grade) or nervous system disease with the potential to affect cognition, Parkinson's disease, or multiple sclerosis.\n9. Routine use of recreational marijuana products (defined as \\> 4 times per month) or illicit drug use per self-reported history within the last 90 days. If using medical cannabis products, it should be stopped at least 1 week prior to inclusion.\n10. Known underlying liver disease (Child-Pugh B or C) or baseline elevation of total bilirubin greater than and\u002For equal to 1.5 x upper limit of normal based on screening laboratory values.\n11. 1Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications.\n12. Patients being treated with anti-seizure or anti-psychotic medications. Patients with a prior history of anti-seizure medication use, who have been off treatment for more than 3 months, are eligible. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) is permitted.\n13. Concomitant treatment with strong inducers of CYP3A4 and\u002For strong inducers of CYP2C19.\n14. Underlying history of epilepsy\u002Frecurrent seizure disorder or unexplained seizure within past 6 months.\n15. Patients with current or lifetime diagnosis of schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \\& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)\n16. Recent history or clinical concern for major depression with suicidal ideation as determined by investigator assessment at baseline\n17. Currently taking medications known to be contraindicated with Epidiolex -FDA-approved CBD (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).\n18. Women who are pregnant or breastfeeding, and individuals of any sex who are capable of reproduction and unwilling to use an effective form of birth control (e.g., condoms, diaphragm, birth control pills, or IUD).\n19. Patients may not be receiving any other investigational agents.",{"count":359,"type":21},[177],"This is a pilot, prospective, randomized study evaluating the feasibility and acceptability of incorporating hemp-derived cannabidiol (CBD) supplementation to prevent oxaliplatin-induced peripheral neuropathy (OIPN) in patients receiving oxaliplatin-based chemotherapy for colorectal cancer (CRC). Participants will be randomized to receive either CBD capsules in addition to standard therapy or standard therapy alone.",[457,458,459],"Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients","Metastatic Colorectal Cancer (CRC)","Peripheral Neuropathy Due to Chemotherapy",[461,462,463,464],"Oxaliplatin-Induced Peripheral Neuropathy (OIPN)","Cannabidiol (CBD)","Colorectal Cancer (CRC)","Neuroprotection","2025-10-20",{"date":467,"type":36},"2025-10-22",{"date":469,"type":36},"2025-10-14",{"date":471,"type":21},"2028-09-07",{"name":42,"class":43},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":480,"enrollmentInfo":481,"targetDuration":483,"studyType":335,"phases":4,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":493,"locationsCount":105},"100497239","african-cancer-genome-gmd-100497239","NCT05754658","African Cancer Genome: GMD","African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers","Inclusion Criteria:\n\n* Male or female patients, 18-85 years of age, diagnosed with a pathologically confirmed cancer at any stage at diagnosis. Participant can have a history of a previous cancer we will control for previous history of cancer diagnosis in our analysis.\n\nExclusion Criteria:\n\n* Patients age \\\u003C18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.","85 Years",{"count":482,"type":21},1500,"1 Year","The goal of this study is to develop a comprehensive characterization of genetic and molecular drivers of breast and prostate cancer in individuals of African ancestry. The study is conducted by the African Caribbean Cancer Consortium (AC3) and involves the recruitment of patients from nine international AC3 research sites in the Bahamas, Barbados, Benin, Burkina Faso, Haiti, Jamaica, Kenya, Namibia, and Trinidad and Tobago, and the US. The main questions are to: molecularly characterize genomic changes in the African Cancer genomes of the breast and prostate and identify the effects of social determinants of health and lifestyle factors on mutational landscape. Black individuals that have been diagnosed with pathologically confirmed prostate or breast cancer will be included. Detailed social determinants of health survey, blood and archived FFPE tissues will be collected. (Tier 1) All patient tissues will be subject to IHC for receptor status (ER, AR, PR Her2\u002Fneu). All patients with available germline DNA from blood will receive genetic screening using a Commercial gene panel testing. (Tier 2) Patient samples with a negative genetic screening will be subject to whole exome sequencing or banked for later RNA or methylation sequencing.",[486,416],"Breast Cancer","2025-10-01",{"date":489,"type":36},"2025-10-06",{"date":491,"type":36},"2022-11-28",{"date":291,"type":21},{"name":42,"class":43},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":238},"100596324","phase-2-gemcitabine-and-carboplatin-after-progression-on-enfortumab-vedotin-and-pembrolizumab-in-advancedmetastatic-urothelial-carcinoma-100596324","NCT07043972","Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced\u002FMetastatic Urothelial Carcinoma","Phase II Study of Second-line Gemcitabine Plus Carboplatin After Progression on Enfortumab Vedotin With Pembrolizumab in Advanced or Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n* Patients must have metastatic or locally advanced histologically and radiographically confirmed urothelial carcinoma\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1\n* Patients must have received treatment with enfortumab vedotin plus pembrolizumab in the first line setting. Study treatment may be started within 28 days of last treatment with EV-P or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient.\n* Age \\> 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must have normal organ and marrow function as defined below.\n\n  * Absolute neutrophil count \\> 1,000\u002Fmm3 unless patient has constitutional neutropenia\n  * Platelets \\> 80,000\u002Ful\n  * Hemoglobin \\> 8.0 g\u002FdL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 x ULN or \\\u003C3.5 x upper limit of normal (ULN) if liver metastases\n  * Creatinine Clearance \\>20 mL\u002Fmin\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Optional: Archival tumor biospecimen, when available, must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study. Formalin fixed paraffin embedded (FFPE) tissue block(s) or at least 15 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.\n\nExclusion Criteria:\n\n* Patients who have had systemic treatment including EV-P or radiotherapy within 2 weeks prior to entering the study\n* Patients who have had systemic treatment including EV-P or radiotherapy within 2 weeks prior to entering the study\n* Patients who have received more than one line of prior therapy or prior platinum-based chemotherapy for locally advanced or metastatic urothelial carcinoma (neoadjuvant platinum-based therapy including cisplatin is allowed)\n* Patients who have not recovered from adverse events to less than Grade 2 secondary to agents administered more than 2 weeks prior to treatment initiation.\n* Patients may not be receiving any other investigational agents\n* Patients with uncontrolled and untreated CNS metastases:\n\n  * Prior radiation to central nervous system (CNS) metastases is permitted\n  * Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence\n  * Patient should not have leptomeningeal disease\n  * CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastases\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit adherence with study requirements\n* Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires tumor- directed treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment (adjuvant hormonal therapy for breast cancer is allowed)\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of chemotherapy (routine antimicrobial prophylaxis is permitted)\n* Pregnant or breast feeding.",{"count":502,"type":21},55,[24],"The goal of this clinical trial is to learn if a chemotherapy combination called gemcitabine and carboplatin (GC) works to treat advanced urothelial cancer in people who have already been treated with enfortumab vedotin and pembrolizumab (EVP).\n\nIt will also learn about the efficacy and safety of GC in these patients.\n\nThe main questions it aims to answer are:\n\n* Does GC shrink the cancer or stop it from growing?\n* What medical side effects do participants have while receiving GC?\n\nResearchers will study how GC affects survival, cancer control, and quality of life. They will also collect blood samples to look at health-related markers and cancer DNA in the blood.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nParticipants will:\n\n* Receive the GC chemotherapy (gemcitabine and cisplatin) after having been treated with EVP\n* Visit the clinic regularly for checkups, lab tests, and scans\n* Answer questions about their health, quality of life, and daily function\n* Provide blood samples for research\n\nThis study may help researchers find better ways to treat advanced bladder and urinary tract cancer in the future-especially for older adults or those who have already tried other treatments.",[338],[507,508,509,510,511],"phase II","locally advanced urothelial cancer","gemcitabine plus carboplatin","enfortumab vedotin plus pembrolizumab","metastatic urothelial cancer","2025-07-15",{"date":514,"type":36},"2025-07-20",{"date":516,"type":36},"2025-07-09",{"date":518,"type":21},"2031-01-01",{"name":42,"class":43},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":105},"100474160","phase-3-post-discharge-risk-based-management-in-patients-undergoing-high-risk-elective-major-cancer-operations-prs-ii-100474160","NCT05454280","Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)","A Randomized Controlled Trial of Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)","First Registration Inclusion Criteria:\n\n* Age \\> 18 years at diagnosis\n* ECOG performance status 0, 1, or 2, defined as\n\nGrade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours\n\n   * Patients must have probable (i.e., clinically suspicious) or histologically\u002Fcytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).\n\nPatients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities are eligible. Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible.\n\nThese procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly \"tracked\" by hospitals and cancer centers participating in the ACS NSQIP Procedure Targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures).\n\n* Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC \\\u003C 30 days after First Registration.\n\nElective surgery is defined as:\n\n* Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND\n* Surgery is not scheduled as urgent or emergent\n\n  * Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n  * Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments.\n\nFirst Registration Exclusion Criteria:\n\n* Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.\n\nSecond Registration Inclusion Criteria:\n\nA patient will be eligible for continued inclusion in this study only if ALL of the following criteria apply at the time of Second Registration (one to two days prior to anticipated discharge). No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.\n\n* Post\n\n  * Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR\n  * Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)\n\nFor the purposes of this study, the procedure that was performed with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of Second Registration as the \"index procedure\" performed during the \"index surgery\".\n\n* Elective surgery \\\u003C 30 days after First Registration.\n\nSecond Registration Exclusion Criteria:\n\n* Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage. This includes patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis.",{"count":528,"type":21},880,[530],"PHASE3","This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).",[228,284],"2025-07-02",{"date":535,"type":36},"2025-07-08",{"date":537,"type":36},"2022-10-14",{"date":539,"type":21},"2028-11-01",{"name":42,"class":43},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":275,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},"100552734","testing-gene-pilotlx-with-latinx-cancer-patients-100552734","NCT06476938","Testing Gene PilotLX With Latinx Cancer Patients","Testing the Efficacy of an eHealth Decision Support Tool to Help Latinx Cancer Patients Make Informed Decisions About Tumor Genomic Testing","Inclusion Criteria:\n\nSelf-identified Latinx patients who:\n\n1. diagnosed with solid tumor cancers\n2. speak\u002Fread English or Spanish;\n3. can provide informed consent.\n\nExclusion Criteria:\n\nPatients with hematologic\u002Fliquid cancers (leukemia, lymphoma, multiple myeloma, etc.)",{"count":549,"type":21},232,[54],"This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase informed decision making regarding hereditary risk information from tumor genomic profiling (TGP) test among Latinx cancer patients recruited at four cancer centers.",[284],[554,555,556],"eHealth decision tool","Hispanic\u002FLatino","Tumor Genomic Profiling","2025-06-30",{"date":559,"type":36},"2025-07-03",{"date":561,"type":36},"2025-05-30",{"date":563,"type":21},"2027-12-31",{"name":42,"class":43},4,{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":105},"100426040","phase-1-a-phase-i-safety-and-pharmacokinetic-study-of-gamitrinib-administered-intravenously-to-patients-with-advanced-cancer-100426040","NCT04827810","A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer","PH-139: A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of advanced cancer refractory to standard of care therapy, or for whom no standard of care therapy is available. Any numbers of prior therapies are allowed.\n* Dose escalation phase: Solid tumors and lymphoma may have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) or as per RECIL 2017 criteria\n* Dose expansion phase:\n\n  i. All patients must have at least one site of measurable disease as defined by RECIST v. 1.1. or RECIL 2017, for solid tumors and lymphoma, respectively ii. Patients in the expansion cohort must have at least one non-target lesion deemed safe to biopsy, in the opinion of the investigator, and be willing to undergo mandatory core biopsies. This includes pre-treatment and an on-treatment biopsy. Biopsies at the time of progression are highly desired, but optional.\n\niii. The lesion(s) which will be used for response assessment may not be biopsied iv. Target lesions that have been previously irradiated will not be considered measurable unless increase in size is observed following completion of radiation therapy\n\n* All previous therapies of cancer, including radiotherapy major surgery and investigational therapies must be discontinued for ≥14 days (≥ 28 days for mitomycin C or nitrosoureas) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy must have resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v5), except alopecia or parameters defined in this eligibility list.\n* Age \\> 18 years.\n* ECOG performance status 0- 2\n* Patients must have normal organ and marrow function as defined below\n* Absolute neutrophil count ≥1,500\u002Fmm3 without growth factor use ≤ 7 days prior to C1D1 Platelets ≥85,000\u002Fmm3 without platelet transfusion ≤ 7 days prior to C1D1 Hemoglobin \\>8.5 mg\u002FdL without red blood cell transfusion ≤ 7 days prior to C1D1 Total serum bilirubin \\\u003C1.5 X upper limit of normal (ULN) (except for patients with documented Gilbert's syndrome) AST (SGOT)\u002FALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if liver dysfunction is felt to be secondary to tumor burden Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2) Serum or urine pregnancy test (WOCBP only) negative ≤7 days of C1D1\n* Ability to understand and willingness to sign a written informed consent, HIPAA consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n* Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.\n\nExclusion Criteria:\n\n* Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases \\> 28 days prior to study entry, including radiotherapy or surgery. Concurrent use of steroids for the treatment of brain metastasis are not permitted.\n* Current treatment on another (therapeutic) clinical trial\n* Hypertension not adequately controlled with medications (\\>150\u002F100 mm Hg despite optimal medical therapy)\n* Active bacterial fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral (Testing is not required for eligibility).\n* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (testing is not required for eligibility).\n* Any of the following in the previous 6 months: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study\n* Pregnant or breast feeding. Refer to section 4.4 for further detail.",{"count":574,"type":21},42,[218],"This is a first-in-human, phase I, open-label, non-randomized dose-escalation and dose-expansion study with the primary objective to determine the safety profile of small molecule, mitochondrial-targeted Hsp90 inhibitor, gamitrinib, including identification of dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) in patients with advanced cancers. A secondary objective of the study is to determine the recommended dose and regimen(s) for a phase II study. This study is based on preclinical data demonstrating the anticancer activity, unique mechanism of action and preliminary safety of gamitrinib.\n\nIn the dose-finding portion of this study, gamitrinib formulated in Lipoid S100®-based formulation will be administered as a 1-hour IV infusion once weekly for four weeks as 28-day treatment cycles. Up to 36 patients will be enrolled in the dose-escalation component of the study based on anticipated cohorts. The starting dose will be 10 mg, corresponding to allometric scaling) from the most sensitive species (rats) in the 29-day GLP toxicology and toxicokinetic studies with 14-day recovery period of gamitrinib. Dose-escalation will follow a 3+3 design. Six patients will be enrolled in the dose-expansion component of the study at MTD for the purpose of exploring pharmacodynamic effects via tumor pre and on-therapy biopsies.",[578,579],"Lymphoma","Advanced Solid Tumor","2025-06-27",{"date":582,"type":36},"2025-06-29",{"date":584,"type":36},"2021-11-05",{"date":586,"type":21},"2026-12-30",{"name":42,"class":43},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":105},"100586375","phase-2-scrambler-therapy-with-duloxetine-based-usual-care-vs-duloxetine-based-usual-care-for-chemotherapy-induced-peripheral-neuropathy-100586375","NCT06914557","Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.","Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.","Inclusion Criteria:\n\n1. Persons aged 18 years or older with cancer\n2. Eastern Cooperative Oncology Group 0-2\n3. At least a 4\u002F10 average pain score prior to treatment\n4. At least CTCAE version 5.0 grade 2 neuropathies.\n5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.\n6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire\n7. Patients must have discontinued neurotoxic chemotherapy within the last 3 months with no additional therapy planned for the next 6 months after initiation of CIPN treatment.\n8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation\n9. Patients must be able to provide informed written consent.\n\nExclusion Criteria:\n\n1. Children or adolescents\n2. Pregnant or nursing patients\n3. Presence of an implantable life supporting medical device or implantable drug delivery system\n4. Patients with severe skin conditions preventing the proper application of electrodes\n5. Patients currently on monoamine oxidase inhibitors MAOIs.\n6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).\n7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)\n8. Patients with leptomeningeal carcinomatosis- treated\u002Fstable brain metastases are allowed\n9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder\n10. Patients with uncontrolled epilepsy.\n11. Patients who have previously attempted or undergone Scrambler therapy.",{"count":596,"type":21},50,[24],"The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications.\n\nOur primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured \"average\" pain score at day 35 to the cross-sectionally measured \"average\" pain score at baseline.",[600,601],"CIPN - Chemotherapy-Induced Peripheral Neuropathy","Pain",[603,604,605,606,607],"CIPN","neuropathy","Chemotherapy-Induced Peripheral Neuropathy","Duloxetine","Scrambler Therapy","2025-04-07",{"date":610,"type":36},"2025-04-09",{"date":612,"type":36},"2025-03-03",{"date":614,"type":21},"2027-06-30",{"name":42,"class":43},{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":623,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":626,"briefSummary":627,"conditions":628,"keywords":632,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":105},"100566220","understanding-the-preferences-and-views-of-older-adults-on-the-use-of-geriatric-and-objective-functional-assessments-for-cancer-treatment-planning-100566220","NCT06652347","Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning.","Facilitating the Engagement and Satisfaction of Older Adults in Their Cancer Care Planning: A Randomized Study to Understand the Preferences and Views of Older Adults Regarding the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning","Inclusion Criteria:\n\n* Age ≥ 65\n\nAt the time of study screening either:\n\n* Started a new qualifying index regimen within the last 30 days (inclusive)\n* Are being considered for a new qualifying index regimen\n\nExclusion Criteria:\n\n* Patients will be excluded if they\n\n  * Do not have the capacity to consent to study procedures\n  * Are unable to complete English language questionnaires\n  * Are already using an activity tracker on a daily basis (and therefore may be aware of their current level of activity)\n  * Are enrolled in another study in which physical activity is a substantial part or all of the therapeutic intervention or where physical activity is specifically being evaluated and shared with patients. Patients on studies not evaluating or sharing physical activity are eligible for the present study if they meet the other inclusion\u002Fexclusion criteria and participation in the present study is not excluded by other studies in which they are enrolled.","65 Years",{"count":625,"type":21},100,[54],"This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care.\n\nThe main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.",[629,630,631],"Care Delivery","Geriatrics","Geriatric Assessment",[633,634,635,636,637,638,639,640,641,642],"fitness tracking","Care delivery Intervention","Functional Status in Older Adults","Cancer Treatment Preferences","Quality vs Quantity of Life","Patient-Reported Outcomes in Oncology","Randomized Controlled Trial","Quality of Life in Cancer care","Functional Health Assessments","Patient-Centered Cancer Treatment","2025-02-25",{"date":645,"type":36},"2025-02-27",{"date":647,"type":36},"2025-02-21",{"date":649,"type":21},"2026-11",{"name":42,"class":43},""]