[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Netherlands Cancer Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":679},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,62,92,117,144,170,196,229,260,281,312,326,348,375,402,427,450,474,502,523,548,570,602,633,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100053384","phase-3-bevacizumab-versus-corticosteroids-as-first-line-treatment-in-patients-with-symptomatic-cerebral-radiation-necrosis-after-radiation-for-high-grade-glioma-or-brain-metastases-100053384",false,"NCT06888817","Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases","Bevacizumab for the Treatment of Cerebral RAdiation Induced NecrosiS (BRAINS) Study: a Multicenter, Open-label, Randomized Clinical Trial to Assess the Clinical Efficacy and Cost-effectiveness of Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases","BRAINS","Inclusion Criteria:\n\nInclusion all patients (both HGG and BM):\n\n1. Age ≥ 18 years old\n2. First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A clear working diagnosis of CRN without evidence of a combination with tumour progression is required\n3. KPS score ≤ 90 and either (a) a minimum loss of two points in at least one domain of the Neurologic Assessment in Neuro-Oncology (NANO) scale as compared to the maximum score of that domain due to sCRN, or (b) a headache attributable to sCRN with an average intensity ≥5\u002F10 on the NRS, persisting for ≥10 consecutive days, with inadequate relief despite an adequate trial of paracetamol and\u002For an NSAID unless these medications are contra-indicated or not tolerated\n4. Maximum daily dexamethasone use of 1 mg\u002Fday for the 8 weeks preceding randomization\n\n   1. Dexamethasone may have been prescribed for various indications, except for managing (ongoing) cerebral edema\n   2. Higher doses of dexamethasone are permitted 3 weeks immediately preceding randomization if used specifically for the treatment of sCRN\n5. Able to understand the patient information, online tests and questionnaires\n6. Written informed consent\n\nInclusion BM:\n\n1\\. BM of solid tumour, including all primary tumour types\n\nInclusion HGG:\n\n1\\. A confirmed histological diagnosis of high-grade diffuse glioma according to WHO 2021 criteria, including: astrocytoma, IDH-mutant, grade 3-4; astrocytoma, IDH-wildtype (sybtype molecular glioblastoma); oligodendroglioma, 1p\u002F19q codeleted, grade 3; diffuse glioma, NEC, grade 3-4; or glioblastoma, IDH-wildtype, grade 4\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study, both for the BM and HGG group:\n\n1. Prior treatment with bevacizumab \\\u003C6 months before diagnosis of sCRN\n2. Life expectancy \\\u003C3 months\n3. Impending radiological or clinical signs of brain herniation necessitating immediate decompressive surgery\n4. Any comorbidity or condition that prevents safe administration of the studied medication, determined by the treating physician, including but not limited to:\n\n   1. Intolerance for murine proteins\n   2. Hypersensitivity or allergy to the active substance or to any of the excipients of bevacizumab or dexamethasone\n   3. Nephrotic syndrome or abnormal renal function\n\n      o Calculated (Cockcroft-Gault) or measured creatinine clearance \\\u003C30 mL\u002Fmin; urine dipstick for proteinuria ≥ 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hr.\n   4. Clinical significant cardiovascular disease\n\n      * Uncontrolled hypertension (systolic BP \\>150mmHg and\u002For diastolic \\>100mmHg) despite the use of ≥ 3 antihypertensive drugs\n      * Previous hypertensive crisis, hypertensive encephalopathy or previous reversible posterior leukoencephalopathy syndrome (RPLS)\n      * Non tumour related vascular event (e.g. cerebral or cardiac ischemia\u002Fbleeding (including transient ischemic attack, cerebral ischemia, unstable angina or angina requiring intervention, myocardial infarction), peripheral arterial thrombus, peripheral artery disease, deep venous thrombosis, lung embolism) \\\u003C 6 months\n      * History of aortic aneurysm or dissection\n      * Congestive heart failure NYHA II-IV\n   5. History of gastro-intestinal fistula, perforation or abscess \\\u003C 6 months\n   6. History of bleeding\n\n      * Relevant pulmonary hemorrhage\u002F hemoptysis \\\u003C 1 month or the presence of a pulmonary lesion with a high risk of bleeding (= central lung tumour and\u002For untreated squamous cell carcinoma) according to the treating physician\n      * Active gastrointestinal bleeding \\\u003C 6 months\n      * Evidence of recent intracranial hemorrhage on MRI brain \\\u003C3 months. Asymptomatic presence of hemosiderin depositions or punctate hemorrhage in the tumour do not serve as a ground for exclusion\n   7. Excess risk of bleeding\n\n      * History or evidence of inherited bleeding diathesis or significant coagulopathy with the risk of bleeding\n      * Decreased platelet count \\\u003C 75x109\u002FL\n   8. Risk of wound healing complications\n\n      * Significant non-healing wound, (peptic) ulcer or bone fracture\n      * Major surgical procedure (including open biopsy) or significant traumatic injury within 28 days prior to first study treatment or planned surgical procedure within the following next 28 days after planned study inclusion\n      * Minor surgical procedure, stereotactic\u002Fcore biopsy, fine needle aspiration within 7 days prior to first study treatment\n   9. High-dose radiotherapy to the mediastinum, abdomen, or lower pelvis; administration of bevacizumab should only be considered after prior consultation with a pulmonologist or oncologist\n   10. Pregnancy or lactation. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to randomization. WOCBP and female partners of male patients must comply with adequate contraception methods as requested by the study protocol\n   11. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the study treatment, affect patient compliance or place the patient at high risk for treatment-related complications according to the treating physician\n   12. Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another interventional study In case of uncertainty, consult the principal investigator of the study site.","ALL","18 Years",{"count":21,"type":22},408,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Cerebral radiation necrosis (CRN) is a severe complication of high-dose radiation for brain metastases (BM) or glioma, which can potentially cause significant neurologic symptoms leading to serious morbidity and impaired quality of life (QoL). The first-line therapy for symptomatic CRN (sCRN) is corticosteroids, primarily dexamethasone, which often leads to complications, refractory symptoms, and interference with anti-cancer treatment. Since 2017, bevacizumab, an antibody against Vascular Endothelial Growth Factor (VEGF), has been used in a second-line treatment setting for refractory sCRN. A small randomized clinical trial (RCT) has shown that bevacizumab significantly diminishes cerebral edema on MRI and decreases clinical symptoms of sCRN in irradiated glioma patients. Several non-randomized clinical studies demonstrated a beneficial radiological and clinical effect of bevacizumab in patients with sCRN after irradiation for BM. The optimal first-line treatment for sCRN is currently unknown. Effective and safe first-line treatment of sCRN will optimize the patient's well-being and health-related QoL. Furthermore, minimizing corticosteroid use will benefit the clinical treatment options and outcomes of concomitant or future anti-cancer treatment. This phase III multicenter, open-label, randomized clinical trial compares the clinical efficacy of first-line bevacizumab versus standard-of-care dexamethasone for sCRN in patients with high-grade glioma (HGG) or BM.",[28,29,30,31,32,33,34],"Radiation Necrosis","High Grade Glioma (III or IV)","Brain Metastasases","Radiation Toxicity","Radiation Effect","Radiation Injury","Radiation Injuries",[36,37,38,39,40,41,42,43,44,45,46,47,48],"Cerebral radiation necrosis","High Grade Glioma","Brain Metastases","Bevacizumab","Dexamethasone","Randomized Clinical Trial","First-line treatment","Anti-VEGF monocolonal antibody","Corticosteroids","Radiation induced necrosis","Radiation effects","Radiation injury","Radiation toxicity","RECRUITING","2026-07-09",{"date":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":53},"2025-06-19",{"date":57,"type":22},"2030-07",{"name":59,"class":60},"The Netherlands Cancer Institute","OTHER",6,{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100517068","phase-1-lb-100-pp2a-inhibitor-and-atezolizumab-pd-l1-inhibitor-in-metastatic-colorectal-cancer-patients-100517068","NCT06012734","LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients","Phase Ib Study With the Combination of LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients - The CoLBAt Trial","CoLBAt","Inclusion Criteria:\n\n1. Signed Informed Consent Form (ICF);\n2. Age ≥ 18 years at time of signing ICF;\n3. Ability to comply with the study protocol;\n4. Histological or cytological confirmed colorectal cancer;\n5. Immunohistochemically confirmation of microsatellite stable (MSS) phenotype;\n6. Disease progression during treatment with standard of care;\n7. Measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation;\n8. Able and willing to undergo blood sampling and tumour biopsies at baseline, if no adequate archival material is available, and during therapy;\n9. Availability of representative tumor specimen for exploratory biomarker research;\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n11. Life expectancy of at least 3 months;\n12. Negative HIV test at screening. Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FµL, and have an undetectable viral load;\n13. Negative hepatitis B test at screening;\n14. Negative hepatitis C virus test at screening;\n15. Adequate hematologic and end-organ function as defined by:\n\n    * Absolute neutrophil (segmented and bands) count ≥1.0×109\u002FL\n    * Lymphocyte count ≥0.5×109\u002FL\n    * Platelets≥100×109\u002FL\n    * Hemoglobin ≥5.6 mmol\u002FL\n    * AST≤2.5×ULN\n    * ALT≤2.5×ULN\n    * AP ≤2.5×ULN\n    * Bilirubin ≤1.5×ULN\n    * Estimated glomerular filtration rate ≥50 mL\u002Fmin by CKD-EPI\n    * Albumin ≥25 g\u002FL\n    * INR ≤1.5×ULN\n    * aPTT ≤1.5×ULN\n16. Negative pregnancy test (urine or serum) for female patients with childbearing potential.\n\nExclusion Criteria:\n\n1. Unable to follow study procedures;\n2. Patients using prohibited medication;\n3. Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia) according to CTCAE version 5.0;\n4. Symptomatic or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with treated or untreated CNS lesions are eligible, provided that all of the following criteria are met:\n\n   * Measurable disease, per RECIST v1.1, must be present outside the CNS;\n   * The patient has no history of intracranial haemorrhage or spinal cord haemorrhage;\n   * The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment;\n   * The patient has no ongoing requirement for corticosteroids as therapy for CNS disease;\n   * If the patient is receiving anti-convulsant therapy, the dose is considered stable;\n5. History of leptomeningeal disease;\n6. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a sta-ble regimen at study entry;\n7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Patients with indwelling catheters are allowed;\n8. Uncontrolled symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected calcium greater than ULN);\n9. Active or history of auto-immune disease or immune deficiency;\n10. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted;\n11. Active tuberculosis;\n12. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina;\n13. Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study;\n14. History of malignancy within 2 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%);\n15. Severe infection within 4 weeks prior to initiation of study treatment;\n16. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics are eligible for the study;\n17. Prior allogeneic stem cell or solid organ transplantation;\n18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications;\n19. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab;\n20. Current treatment with anti-viral therapy for HBV;\n21. Treatment with investigational therapy within 28 days prior to initiation of study treat-ment;\n22. Prior treatment with CD137 agonists or immune checkpoint blockade therapies;\n23. Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment;\n24. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment;\n25. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins;\n26. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the Atezolizumab formulation;\n27. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.",{"count":71,"type":22},37,[73],"PHASE1","This Phase Ib trial studies the side effects and best dose of LB-100 when given with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of the tumor to grow and spread. LB-100 has been shown to make anticancer drugs work better at killing cancer. LB-100 blocks a protein on the surface of cells called PP2A. Blocking this protein increases the stress signals for the tumor cells that express PP2A. Giving atezolizumab in combination with LB-100 may work better to treat metastatic colorectal cancer patients as the cancer cells that experience increased stress signals are more susceptible for the immunotherapy.",[76],"Metastatic Microsatellite-stable Colorectal Cancer",[78,79,80,81,82],"Gastrointestinal Neoplasms","Colorectal cancer","Metastatic colorectal cancer","Microsatellite stable","Immune checkpoint inhibitors","2026-06-26",{"date":85,"type":53},"2026-06-29",{"date":87,"type":53},"2024-06-18",{"date":89,"type":22},"2028-07",{"name":59,"class":60},1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100643935","phase-2-enfortumab-vedotin--pembrolizumab-induction-to-spare-the-bladder-in-mibc-100643935","NCT07663747","Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC","A Phase 2 Study to Assess Efficacy of Induction Enfortumab Vedotin Plus Pembrolizumab Using a Response-adapted Approach to Spare the Bladder: FIDELIO","FIDELIO","Inclusion Criteria:\n\n1. Participants who are at least 18 years of age on the day of signing informed consent.\n2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n3. Patients with histologically confirmed cT2-4aN0-1M0 urothelial bladder cancer, seeking an alternative to radical cystectomy and\u002For patients who are medically unfit for surgery.\n\n   Variant histology allowed, exceptions:\n   * no pure (\\>90%) squamous\n   * no \\>50% adenocarcinoma\n   * no \\>50% sarcomatoid component\n   * no \\>10% plasmacytoid component\n   * no small cell component\n4. Archival tumor tissue sample or newly obtained TURB of the bladder tumor is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n6. Have adequate organ function as defined in Table 3 below. Specimens must be collected within 14 days prior to the start of study intervention.\n7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Not of childbearing potential (see section 9.2.1) OR\n   * Of childbearing potential and:\n\n     * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 120 days (pembrolizumab) or 180 days (EV) after the last dose of study intervention and agrees not to donate ova to others or freeze\u002Fstore for her own use for the purpose of reproduction before start of study treatment. More details on contraceptive guidance can be found in section 9.2.1. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n     * Has a negative urine or serum pregnancy test within 72 hours before the first dose of study intervention. Female subjects with false positive results and documented verification of negative pregnancy status may be eligible in consultation with the sponsor.\n     * Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention (for pembrolizumab) or 180 days (EV) after the last dose of study intervention.\n\nA male participant agrees to the following during the intervention period and for at least 180 days after the last dose of EV:\n\nRefrains from donating sperm plus either:\n\n* Abstains from heterosexual intercourse as their preferred and usual lifestyle and agrees to remain abstinent\n* Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)\n\nExclusion Criteria:\n\n1. Previous pelvic irradiation\n2. Upper tract urothelial cancer\n3. Extensive carcinoma in situ (CIS) of the bladder\n4. Bilateral hydronephrosis\n5. Previous intravenous systemic therapy for bladder cancer, including chemotherapy, checkpoint inhibition or antibody-drug conjugate.\n6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n7. Contra-indication to one of the study treatment components\n8. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n10. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Exceptions: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n11. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, EV and\u002For any of its excipients in drug formulations (including histidine, trehalose dihydrate, and polysorbate 20).\n12. Has active autoimmune disease that has required systemic treatment in the past 2 years. Exceptions that can still be included:\n\n    * Endocrine disease with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n    * Patients with vitiligo, psoriasis or other mild skin disease\n    * Gout is not considered an auto-immune disease. Patients should not have had an episode of active arthritis within 30 days of start of therapy.\n13. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n14. Ongoing sensory or motor neuropathy Grade 2 or higher.\n15. Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.\n16. A history of uncontrolled diabetes. Uncontrolled diabetes is defined as HbA1c ≥8% or HbA1c 7% to \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n17. Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Active infection requiring systemic therapy is excluded as well.\n18. Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n\n    HIV-positive patients are eligible if the following applies:\n    * Receives antiretroviral therapy (ART), without changes in drugs or dose modification, for at least 4 weeks prior to treatment and continued while enrolled on study.\n    * CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    * Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n    * No AIDS defining opportunistic infection within the past 12 months, or a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n    * In patients with a known history of hepatitis B infection, Hepatitis B surface antigen should be negative at time of screening. Patients having chronic hepatitis B are not eligible.\n    * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n19. Has not adequately recovered from major surgery or has ongoing surgical complications.\n20. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for the disease under study.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":101,"type":22},56,[103],"PHASE2","This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach",[106],"Urothelial Bladder Cancer","NOT_YET_RECRUITING","2026-06-23",{"date":110,"type":53},"2026-06-25",{"date":112,"type":22},"2026-09-01",{"date":114,"type":22},"2032-04-01",{"name":59,"class":60},3,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100587698","tao-towards-optimal-neoadjuvant-systemic-therapy-of-stage-iii-triple-negative-breast-cancer-100587698","NCT06931769","TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer","TAO","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Histologically confirmed adenocarcinoma of the breast\n* Assumed clinical or pathological stage III (TNM) breast cancer\n* Breast tumor must be:\n\n  * HER2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)\n  * Hormone receptor negative i.e. an estrogen receptor (ER) of \\\u003C10% and progesterone receptor (PR) of \\\u003C10%.; or in case of a histological grade III tumor an ER of \\\u003C50% and a PR of \\\u003C50%.\n* Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise\n* Participating patients have to be able to use a mobile phone, tablet, laptop and\u002For computer and understand the Dutch language\n\nExclusion Criteria:\n\n* Evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines.\n* Patients who are only treated systemically in the adjuvant setting\n* Participation in another clinical study with an treatment intervention during the course of this study.",{"count":125,"type":22},100,"OBSERVATIONAL","This prospective, national, multi-centre study will include patients with stage III triple-negative breast cancer (TNBC) who are planned to start with standard (neo)adjuvant systemic treatment. The study will gather clinico-pathological, treatment and follow-up information of participating patients through Dutch databases. Participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at nine time points during and after their anticancer treatment in a mobile application.\n\nFor all patients who have consented to additional blood collection, to assess the course of dynamic ctDNA during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.",[129],"Breast Cancer",[131,132,133,134],"Stage III","Triple Negative","Neo adjuvant treatment","Quality of Life","2026-05-11",{"date":137,"type":53},"2026-05-13",{"date":139,"type":53},"2025-11-06",{"date":141,"type":22},"2030-07-01",{"name":59,"class":60},7,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":91},"100633136","long-term-survivorship-challenges-of-advancedmetastatic-gist-patients-responding-to-tyrosine-kinase-inhibitor-treatment-an-observational-study-100633136","NCT07522762","Long-term Survivorship Challenges of Advanced\u002FMetastatic GIST Patients Responding to Tyrosine Kinase Inhibitor Treatment: an Observational Study","Long-term Survivorship Challenges of Advanced\u002FMetastatic GIST Patients Responding to Tyrosine Kinase Inhibitor Treatment: an Observational Study (EORTC-1944)","Inclusion Criteria:\n\n* Age 18 years or older (no upper age limit);\n* Advanced or metastatic GIST, diagnosis of GIST must be histologically proven;\n* Treated with TKIs (eg. sunitinib, regorafenib, avapritinib, ripretinib) for at least 2 years; TKI treatment ongoing; interruptions up to 3 months are allowed;\n* Able to read and answer questionnaires;\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Patients receiving TKI in an adjuvant treatment setting.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion the study.\n* Patients who are too ill (death is imminent), as determined by the referring health care professional.",{"count":152,"type":22},330,"Gastrointestinal stromal tumours (GISTs) are rare malignancies arising along the gastrointestinal tract. Tyrosine kinase inhibitors (TKIs) have substantially improved survival for patients with unresectable or metastatic GIST. As a result, an increasing number of patients live with advanced disease under chronic TKI therapy, highlighting the need to understand long-term survivorship, including health-related quality of life (HRQoL), treatment burden, and clinical outcomes.\n\nThis international, multicentre observational study includes two components: a retrospective cross-sectional study to evaluate the relevance and applicability of patient-reported outcome instruments, and a prospective cohort to document long-term clinical outcomes, HRQoL, treatment patterns, and survivorship challenges.\n\nParticipants will include adults with advanced or metastatic GIST who have received TKI therapy for at least 2 years. Data will be collected from medical records and through validated patient-reported outcome questionnaires at baseline and annually for up to 10 years. This study aims to provide insight into HRQoL problems, treatment discontinuation, coping strategies, and the impact of financial toxicity among long-term survivors of GIST.",[155],"Gastrointenstinal Stromal Tumor (GIST)",[157,158,159,160,161],"Gastrointestinal Stromal Tumor (GIST)","Tyrosine Kinase Inhibitor","Imatinib","Health-related quality of life","Metastatic disease","2026-04-08",{"date":164,"type":53},"2026-04-13",{"date":166,"type":53},"2025-05-21",{"date":168,"type":22},"2037-05-21",{"name":59,"class":60},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":91},"100632303","novel-ga68-psma-petct-tracer-to-differentiate-between-radiation-necrosis-and-tumor-progression-in-brain-metastases-100632303","NCT07511933","Novel Ga68-PSMA PET\u002FCT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases","Novel Ga68-PSMA PET\u002FCT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases. A Feasibility Study.","Inclusion Criteria:\n\nFor all groups:\n\n* Written informed consent\n* Age ≥ 18 years old\n* WHO PS 0-3\n* Measurable lesion ≥10mm according to RANO BM\n\nFor brain metastases groups:\n\n\\- newly diagnosed brain metastases from either NSCLC (group 1) or melanoma (group 2) or breast cancer (group 7).\n\nFor radiation necrosis groups:\n\n\\- Brain lesion at the location of a formerly brain metastases that has been treated with SRT (\\> 9 months ago), with the definite diagnosis of radiation necrosis at the location of formerly SRT-treated brain metastases of NSCLC (group 3), melanoma (group 4) and\u002F or breast cancer (group 8).\n\nFor diagnostic dilemma groups:\n\n\\- Brain lesion at the location of a formerly brain metastases with a diagnostic dilemma of radiation necrosis and recurrent brain metastases of NSCLC (group 5), melanoma (group 6) and\u002F or breast cancer (group 9).\n\nExclusion Criteria:\n\nFor all groups:\n\n* Known allergy to Ga68-PSMA\n* Epileptic seizure less than 7 days before Ga68-PSMA PET\u002FCT scan\n* Life expectancy less than 3 months\n* Patients with known prostate carcinoma\n* Pregnancy",{"count":125,"type":22},[179],"NA","This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET\u002FCT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.",[182,183,184],"Brain Metastases From Non-small Cell Lung Cancer (NSCLC)","Brain Metastases From Melanoma","Brain Metastases From Breast Cancer",[38,28,186,187],"Diagnostic Imaging","Radiation-induced Toxicity","2026-03-30",{"date":190,"type":53},"2026-04-06",{"date":192,"type":53},"2019-12-24",{"date":194,"type":22},"2027-07-01",{"name":59,"class":60},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":214,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100630362","phase-3-pembrolizumab-adjuvant-in-patients-with-early-stage-triple-negative-breast-cancer-with-residual-disease-after-neoadjuvant-pembrolizumab-plus-chemotherapy-100630362","NCT07486687","Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy","PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial","PLANET","Inclusion Criteria:\n\n1. Male or female, ≥18 years of age on day of signing informed consent\n2. Stage II or III TNBC prior to the start of neoadjuvant treatment\n\n   1. Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8\n   2. Locally assessed estrogen receptor (ER) and\u002For progesterone receptor (PR) expression \\\u003C10% and HER2-negative according to the ASCO-CAP guideline1\n3. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab\n4. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study\n5. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score \\>02\n6. World Health Organization (WHO) performance status 0-2\n7. Adequate organ function, as assessed ≤30 days prior to the screening:\n\n   1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 (1.0 x 10e9 \u002FL)\n   2. Platelets ≥50,000\u002Fmm3 (50 x 10e9 \u002FL);\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the method standard for the institution;\n   4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);\n   5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN\n8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication\n9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n10. Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national\u002Flocal regulations\n\nExclusion Criteria:\n\n1. Contra-indications for any of the study drugs\n2. Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago\n3. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n4. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study",{"count":205,"type":22},1000,[25],"The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.",[209,210,211,212,213],"Triple Negative Breast Cancer (TNBC), Early Setting","Early Stage Triple-Negative Breast Carcinoma","Triple -Negative Breast Cancer","Breast Cancer Stage II","Breast Cancer Stage III",[215,216,217,218,219,220],"Immunotherapy","Pembrolizumab","Triple negative breast cancer","Breast cancer","TNBC","Adjuvant","2026-03-17",{"date":223,"type":53},"2026-03-20",{"date":225,"type":22},"2026-04",{"date":227,"type":22},"2036-04",{"name":59,"class":60},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":236,"minAge":19,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":91},"100628326","phase-1-the-proov-study-exploiting-the-synergistic-effect-of-parp-inhibition-with-cisplatin-and-hyperthermia-during-interval-cytoreductive-surgery-and-hipec-in-ovarian-cancer-100628326","NCT07460180","The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer","PROOV","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n  * Signed and written informed consent\n  * At least 18 years of age and able to understand patients' information\n  * FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.\n  * FIGO stage IV is allowed in the following situations:\n\n    * Resectable stage IV desease, such as local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions\n    * Stage IV based on cardiophrenic lymph nodes \\\u003C1cm\n  * The diagnosis should be confirmed with either histology or cytology. If the diagnosis of ovarian carcinoma is based on cytology only, immunohistochemistry, including keratin 7, keratin 20, p53, PAX8 should be considered for confirmation of the diagnosis (at the discretion of the pathologist)\n  * Eligible and planned for interval cytoreductive surgery with HIPEC\n\n    * Neo-adjuvant chemotherapy consists of at least 3 courses of carboplatin\u002Fpaclitaxel\n    * Patients should have response or stable disease after NACT; no progression should occur\n    * Operability has been evaluated in a multidisciplinary team (MDT) meeting via CT scan, MRI or diagnostic laparoscopy and an optimal or complete interval CRS is deemed feasible\n  * Fit for major surgery, WHO performance status 0-2\n  * Adequate bone marrow function (hemoglobin level \\>5.5 mmol\u002FL, leukocytes \\>3 x10\\^9\u002FL, platelets \\> 100 x10\\^9\u002FL)\n  * Adequate hepatic function (ALT, AST, and bilirubin \\\u003C 2.5 times the upper limit of normal)\n  * Adequate renal function (creatinine clearance ≥ 60 ml\u002Fmin using Cockcroft-Gault formula or 24-hour measurement or ml\u002Fmin\u002F1,73 m2 using MDRD or CKD-EPI)\n\nExclusion Criteria:\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n  * History of previous malignancy treated with chemotherapy\n  * Opting for fertility-sparing surgery\n  * Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP \"G-standaard\" that cannot be stopped temporarily","FEMALE","100 Years",{"count":239,"type":22},55,[73,103],"The PROOV study is an open-label, monocenter, single-arm, prospective phase I\u002FII trial with a safety lead-in, evaluating the feasibility of combining PARPi with HIPEC in stage III EOC patients. Phase I is a dose-finding phase with a time-to-event Bayesian Optimal Interval (TITE-BOIN) design, in which three doses of olaparib are evaluated to identify the optimal dose for the phase II part and future trials. The recommended phase II dose (RP2D) will be determined based on the experienced DLTs per dose level and the level of intra-tumor and systemic enzymatic PARP inhibition. During Phase II, the safety profile of the RP2D will be assessed in a total cohort of 40 patients. To provide a proof-of-concept, efficacy will be explored in both translational analyses and survival data.",[243,244,245],"Ovarian Cancer","Epithelial Cancer","Fallopian Tube Cancer",[247,248,249,250,251],"safety","efficacy","PARP inhibitor","HIPEC","Hyperthermic intraperitoneal Chemotherapy","2026-03-05",{"date":254,"type":53},"2026-03-10",{"date":256,"type":53},"2025-05-01",{"date":258,"type":22},"2032-05-01",{"name":59,"class":60},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":91},"100537538","phase-2-pan-tumor-neoadjuvant-basket-study-of-immune-check-point-inhibition-and-novel-immuno-oncology-combinations-100537538","NCT06279130","Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations","NEOASIS","Inclusion Criteria:\n\n1. Signed written informed consent\n2. Patients at least 18 years of age\n3. Non-metastatic, newly diagnosed dMMR and pMMR cancers either fitting within a specific basket or in the \"other\" cohort (e.g. sarcoma, head and neck cancers, anal cancer, esophageal SCC)\n4. In case of pMMR tumors: no indication for neoadjuvant therapy according to standard of care, unless adjuvant treatment is considered a standard of care alternative;\n5. Eligible for study biopsy\n6. World health organization (WHO) performance status of 0 or 1\n7. Screening laboratory tests must meet the following criteria and should be obtained within 7 days prior to randomization\u002Fregistration: White blood cell count (WBC \\> 2.0 x 10\\^9\u002FL, Absolute neutrophil count (ANC) \\> 1.5x10\\^9\u002FL, platelets \\> 100 x 10\\^9\u002FL, Hemoglobin \\> 5.0mmol\u002FL. Transfusion is allowed to obtain an adequate hemoglobin level. Liver function tests: total bilirubin \\\u003C 1.5 upper limit of normal (ULN) (except for subjects with Gilbert syndrome, who can have total bilirubin \\\u003C3.0 mg\u002FdL); alkaline phosphatase \\\u003C1.5 ULN; transaminases (ASAT\u002FALAT) \\\u003C3 x ULN; Lactate dehydrogenase (LDH) \\\u003C 1.5x ULN; Creatinine clearance (Cockcroft-Gault) of \\>45 ml\u002Fmin, Albumin \\> 3.0 g\u002FdL\n8. Women of childbearing potential (WOCBP)\\* must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 20 weeks after the last dose of investigational drug, Non-childbearing potential is defined as:\n\n   1. Postmenopausal: ≥ 50 years of age and has not had menses for greater than 1 year.\n   2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle- stimulating hormone value in the postmenopausal range upon pre-study(screening) evaluation.\n   3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n9. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of cycle 1 day 1\n10. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving the study treatment and who are sexually active with WOCBP (excluding azoospermic men) will be instructed to adhere to contraception for a period of 28 weeks after the last dose of investigational drug and are not allowed to donate sperm during that timeframe.\n\nExclusion Criteria:\n\n1. Signs of distant metastases on imaging and physical examination\n2. Clinical obstruction\n3. Clinical symptoms or radiological suspicion of perforation\n4. Previous treatment with immune checkpoint inhibitors including but not limited to anti-CTLA4 or anti-PD1\n5. Prior chemotherapy for any cancer\n6. Radiotherapy prior to or planned post-surgery radiotherapy for disease under study\n7. Active malignancies other than disease under study within 3 years prior to inclusion, except for malignancies with a negligible recurrence rate (e.g. \\\u003C10% in 5 years)\n8. Allergies and Adverse Drug Reaction:\n\n   1. History of allergy to study drug components\n   2. History of severe hypersensitivity reaction to any monoclonal antibody\n9. Intercurrent illnesses, including but not limited to infections, unstable angina pectoris\n10. Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity determination of adverse events\n11. Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection\n12. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n13. Active autoimmune disease or a documented history of autoimmune disease, or other medical conditions requiring systemic steroid or immunosuppressive medications, except for subjects with vitiligo, diabetes mellitus type 1, hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis or resolved childhood asthma\u002Fatopy not requiring systemic treatment\n14. Conditions requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) 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\n15. Live vaccines in the 4 weeks prior to inclusion\n16. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n17. Current pregnancy or breastfeeding\n\nSpecific for pMMR GEA cohort:\n\nKnown DPD deficiency; refer local clinical guidance, for DPD status recommendation prior to starting treatment.",{"count":268,"type":22},133,[103,25],"In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.",[272,273],"Resectable MMR-deficient Solid Tumors","Resectable MMR-proficient Solid Tumors","2026-03-03",{"date":252,"type":53},{"date":277,"type":53},"2024-01-29",{"date":279,"type":22},"2034-01-29",{"name":59,"class":60},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":61},"100287781","phase-2-neoadjuvant-immune-checkpoint-inhibition-and-novel-io-combinations-in-early-stage-colon-cancer-100287781","NCT03026140","Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer","Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)","NICHE","Inclusion criteria:\n\n* Signed written informed consent\n* Patients at least 18 years of age\n* Non-metastatic adenocarcinoma of the colon (and rectosigmoid considered as nonrectal and not undergoing neoadjuvant treatment)\n\n  * No signs of distant metastases on CT-scan and physical examination;\n  * dMMR cohorts 3+6: \\>cT3 and\u002For N+\n\nExclusion criteria:\n\n* No signs of distant metastases\n* No signs of obstruction or macroscopic bleeding or suspicion of perforation\n* Colonoscopy must be performed after registration to obtain study-specific biopsies. If biopsies are not possible, patients cannot be included in the study\n* WHO performance status of 0 or 1\n* No previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1\n* For patients with MSS tumors: no current use of NSAIDs or COX2-inhibitors at registration and no active peptic ulcer, gastrointestinal bleeding, unstable ischemic heart disease of thrombus etiology or significant established ischemic heart disease, peripheral arterial disease and\u002For cerebrovascular disease\n* No radiotherapy prior to or planned post-surgery radiotherapy\n* No history of allergy to study drug components, severe hypersensitivity reaction to any monoclonal antibody, allergy or severe hypersensitivity to NSAIDs or COX2-I (MSS tumors)\n* No intercurrent illnesses, including but not limited to infections, unstable angina pectoris\n* No positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection\n* No autoimmune disease\n* No conditions requiring systemic treatment with either corticosteroids (10 mg daily prednisone or more and equivalents) or other immunosuppressive medications within 14 days of study drug administration\n* No live vaccines in the 4 weeks prior to inclusion",{"count":290,"type":22},353,[103],"In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.",[294],"Colon Carcinoma",[296,297,298,299,300,301,302,303,304,305],"MSI tumors","MSS tumors","short-term immunotherapy","surgical resection","nivolumab","ipilimumab","COX2","Anti-IL8","Relatlimab","Anti-LAG3",{"date":252,"type":53},{"date":308,"type":53},"2017-03-29",{"date":310,"type":22},"2032-03-01",{"name":59,"class":60},{"id":313,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":26,"conditions":317,"keywords":318,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":324,"locationsCount":325},"100584398","Inclusion Criteria:\n\nInclusion all patients (both HGG and BM):\n\n1. Age ≥ 18 years old\n2. First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A clear working diagnosis of CRN without evidence of a combination with tumour progression is required\n3. KPS score ≤ 90 and a minimum loss of two points in at least one domain of the NANO scale as compared to the maximum score of at that domain due to sCRN\n4. Maximum daily dexamethasone use of 1 mg\u002Fday for the 8 weeks preceding randomization\n\n   1. Dexamethasone may have been prescribed for various indications, except for managing (ongoing) cerebral edema\n   2. Higher doses of dexamethasone are permitted during the week immediately preceding randomization if used specifically for the treatment of sCRN\n5. Able to understand the patient information, online tests and questionnaires\n6. Written informed consent\n\nInclusion BM:\n\n1\\. BM of solid tumour, including all primary tumour types\n\nInclusion HGG:\n\n1\\. A confirmed histological diagnosis of high-grade diffuse glioma according to WHO 2021 criteria, including: astrocytoma, IDH-mutant, grade 3-4; astrocytoma, IDH-wildtype (sybtype molecular glioblastoma); oligodendroglioma, 1p\u002F19q codeleted, grade 3; diffuse glioma, NEC, grade 3-4; or glioblastoma, IDH-wildtype, grade 4\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study, both for the BM and HGG group:\n\n1. Prior treatment with bevacizumab \\\u003C6 months before diagnosis of sCRN\n2. Life expectancy \\\u003C3 months\n3. Impending radiological or clinical signs of brain herniation necessitating immediate decompressive surgery\n4. Any comorbidity or condition that prevents safe administration of the studied medication, determined by the treating physician, including but not limited to:\n\n   1. Intolerance for murine proteins\n   2. Hypersensitivity or allergy to the active substance or to any of the excipients of bevacizumab or dexamethasone\n   3. Nephrotic syndrome or abnormal renal function\n\n      o Calculated (Cockcroft-Gault) or measured creatinine clearance \\\u003C30 mL\u002Fmin; urine dipstick for proteinuria ≥ 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hr.\n   4. Clinical significant cardiovascular disease\n\n      * Uncontrolled hypertension (systolic BP \\>150mmHg and\u002For diastolic \\>100mmHg) despite the use of ≥ 3 antihypertensive drugs\n      * Previous hypertensive crisis, hypertensive encephalopathy or previous reversible posterior leukoencephalopathy syndrome (RPLS)\n      * Non tumour related vascular event (e.g. cerebral or cardiac ischemia\u002Fbleeding (including transient ischemic attack, cerebral ischemia, unstable angina or angina requiring intervention, myocardial infarction), peripheral arterial thrombus, peripheral artery disease, deep venous thrombosis, lung embolism) \\\u003C 6 months\n      * History of aortic aneurysm or dissection\n      * Congestive heart failure NYHA II-IV\n   5. History of gastro-intestinal fistula, perforation or abscess \\\u003C 6 months\n   6. History of bleeding\n\n      * Relevant pulmonary hemorrhage\u002F hemoptysis \\\u003C 1 month or the presence of a pulmonary lesion with a high risk of bleeding (= central lung tumour and\u002For untreated squamous cell carcinoma) according to the treating physician\n      * Active gastrointestinal bleeding \\\u003C 6 months\n      * Evidence of recent intracranial hemorrhage on MRI brain \\\u003C3 months. Asymptomatic presence of hemosiderin depositions or punctate hemorrhage in the tumour do not serve as a ground for exclusion\n   7. Excess risk of bleeding\n\n      * History or evidence of inherited bleeding diathesis or significant coagulopathy with the risk of bleeding\n      * Decreased platelet count \\\u003C 75x109\u002FL\n   8. Risk of wound healing complications\n\n      * Significant non-healing wound, (peptic) ulcer or bone fracture\n      * Major surgical procedure (including open biopsy) or significant traumatic injury within 28 days prior to first study treatment or planned surgical procedure within the following next 28 days after planned study inclusion\n      * Minor surgical procedure, stereotactic\u002Fcore biopsy, fine needle aspiration within 7 days prior to first study treatment\n   9. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hr.\n   10. Previous, current or planned high dose radiotherapy in the abdomen\n   11. Pregnancy or lactation. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to randomization. WOCBP and female partners of male patients must comply with adequate contraception methods as requested by the study protocol\n   12. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the study treatment, affect patient compliance or place the patient at high risk for treatment-related complications according to the treating physician\n   13. Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another interventional study In case of uncertainty, consult the principal investigator of the study site.",{"count":21,"type":22},[25],[28,29,30,31,32,33,34],[36,37,38,39,40,41,42,43,44,45,46,47,48],"2026-02-24",{"date":321,"type":53},"2026-02-25",{"date":55,"type":53},{"date":57,"type":22},{"name":59,"class":60},5,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":91},"100626532","phase-1-whole-body-her2-quantification-with-89zr-trastuzumab-petct-to-asses-zr-trastuzumab-accumulation-in-her2-mutated-and-her2-overexpressing-metastatic-non-small-cell-lung-cancer-100626532","NCT07436858","Whole Body HER2 Quantification With 89Zr-Trastuzumab PET\u002FCT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed written informed consent\n* Age≥ 18 years, willing and able to comply with the protocol as judged by the investigator\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at screening.\n* Patients with histologically or cytologically confirmed diagnosis of advanced stage:\n* HER2 overexpression, defined as an immunohistochemistry score (IHC) of 2+ or 3+ in at least 10% of tumour cells without an activating HER2 mutation\n* HER2 activating (insertion) mutation diagnosed through RNA sequencing (RNAseq)\n* Disease progression after at least one line of platinum-based chemotherapy ± immunotherapy and starting (new) systemic treatment.\n* Be willing to provide a recent tumor tissue specimen after the last line of therapy. Samples must be of sufficient quantity and of adequate tumor tissue content.\n* Able to undergo PET imaging procedures.\n* Measurable disease according to RECIST 1.1.\n* At least two measurable lesions with a long axis diameter ≥2 cm.\n* Adequate organ and bone marrow function within 21 days prior to tracer injection, defines as:\n\nLaboratory Test Laboratory Value Platelet count ≥100 000\u002Fmm3 or ≥100 × 109\u002FL (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) Hemoglobin ≥9.0 g\u002FdL or 5.6 mmol\u002FL (transfusion and\u002For growth factor support is allowed) Absolute neutrophil count (ANC) ≥1500\u002Fmm3 or ≥1.5 × 109\u002FL Aspartate aminotransferase \u002Falanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 ×ULN) Total bilirubin ≤1.5 × ULN if no liver metastases (\\\u003C3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases Creatinine Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n\nInternational normalised ratio (INR)\u002FProthrombin time and activated partial thromboplastin time (aPTT) ≤1.5 × (ULN), except for subjects on coumarinderivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n\n* Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n* Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n* Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3. from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Highly Effective Methods of Contraception (\\\u003C1% failure rate) include:\n\n  * Total heterosexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)\n  * Vasectomised sexual partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)\n  * Bilateral tubal occlusion\n  * Intrauterine device (provided coils are copper banded)\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation i. Oral ii. Intravaginal iii. transdermal\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral\u002Finjectable\u002Fimplantable)\n  * Intrauterine hormone-releasing system (IUS)\n  * All methods of contraception must be used in combination with the use of a condom by their male sexual partners for intercourse.\n\nExclusion Criteria:\n\n* Contraindications for systemic treatment (as will be assigned by the treating physician)\n* Pregnant or lactating women\n* Prior allergic reaction to immunoglobulins or immunoglobulin allergy\n* Inability to comply with study procedures\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the study results\n* Prior treatment with HER2-targeted therapies (except pan HER TKIs).",{"count":333,"type":22},20,[73],"The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.",[337,338,339],"Lung Cancer (NSCLC)","HER2 Expression","HER2 Gene Mutation","2026-02-23",{"date":342,"type":53},"2026-02-27",{"date":344,"type":22},"2026-08-01",{"date":346,"type":22},"2030-06-01",{"name":59,"class":60},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":364,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":61},"100598456","short-course-of-radiotherapy-prior-to-surgery-of-soft-tissue-sarcomas-100598456","NCT07071727","Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas","Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Second Randomized Phase II Clinical Trial","SCOPES II","Inclusion Criteria:\n\n* Histologically confirmed intermediate to high grade soft tissue sarcoma localized to the head and neck area, to the trunk and chest wall or to the extremities, for which the standard treatment is a combination of and radiotherapy and surgery (deep seated and\u002For ≥ 5cm in largest tumor diameter and\u002For an anticipated close resection margin and\u002For grade II\u002FIII according to the FNCLCC definition);\n* Absence of regional and\u002For distant disease. Patients must be staged by at least a CT scan of the chest. Staging may also be performed by FDG-PET scanning and\u002For total body MRI scans;\n* WHO Performance Status ≤ 2;\n* Able and willing to undergo preoperative radiotherapy;\n* Able and willing to undergo definitive surgery;\n* Able and willing to comply with regular follow-up visits;\n* Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness);\n* Able and willing to undergo randomization;\n* Age ≥ 18 years;\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma;\n* Patients with locally recurrent sarcomas, regardless of the management of the first sarcoma diagnosis;\n* Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;\n* Myxoid liposarcomas, because they have shown to be exquisitely sensitive to a lower dose of radiation as compared to the 2 regimens tested in this trial.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n* Female patients who are pregnant;\n* Intention to perform an isolated limb perfusion, instead of a tumor resection;\n* Neoadjuvant chemotherapy both before and after radiotherapy.",{"count":357,"type":22},150,[179],"Based upon the preliminary data derived from first SCOPES clinical trial and the results of patients treated during the recent COVID-19 pandemic, patients with soft tissue sarcomas (STS) can be preoperatively irradiated in a modestly hypofractionated schedule of 14 x 3 Gy. From a toxicity and efficacy point of view, this regimen equals the outcomes after a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Moreover, the rationale for investigating (modest) hypofractionation in the clinic comes both from a logistic point of view (patient convenience and a lower pressure on radiotherapy equipment), form prior phase II clinical evidence and from (cellular) radiobiological observations. There is phase II trial evidence suggesting that even more (ultra-) hypofractionation to 5 x 6 Gy is also safe and effective. Within this study, patients will be randomized to receive either the modestly hypofractionated conventional schedule of 14 x 3 Gy or an even shorter preoperative regimen of 5 x 6 Gy, in the hypothesis that both the postoperative wound complication rate until 120 days after surgery, as well as the local control probability at two years are comparable in both arms.",[361,362,363],"Sarcoma of Soft Tissue","Sarcoma","Sarcoma, Soft Tissue",[365,366],"preoperative radiotherapy","radiotherapy","2026-02-16",{"date":369,"type":53},"2026-02-19",{"date":371,"type":53},"2025-12-11",{"date":373,"type":22},"2033-11-01",{"name":59,"class":60},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":383,"minAge":19,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":91},"100623080","dose-de-escalation-in-prostate-radiotherapy-using-an-mr-linac-in-two-fractions-100623080","NCT07391982","Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions","Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions","DESTINATION 2","Inclusion Criteria:\n\n1. Men aged ≥18 years\n2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy\n3. Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)\n4. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +\u002F- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and \\\u003C2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry\n5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).\n6. MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)\n7. PSA \\\u003C20 ng\u002Fml prior to starting androgen deprivation therapy (ADT).\n8. WHO Performance status 0-2\n9. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.\n10. Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)\n2. IPSS Score \\> 19\n3. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.\n4. Prostate volume \\>90cc\n5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up\n6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging\n7. Previous pelvic radiotherapy\n8. Patients needing \\>6 months of ADT due to disease parameters.\n9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.","MALE",{"count":385,"type":22},54,[179],"The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.\n\nThe main questions it aims to answer are:\n\n* Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?\n* Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?\n\nResearchers will compare two treatment approaches:\n\n* One group receives a uniform high dose to the entire prostate.\n* The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.\n\nParticipants will:\n\n* Receive two sessions of MRI-guided radiotherapy using an MR-Linac.\n* Complete questionnaires about urinary, bowel, and sexual health before and after treatment.\n* Have follow-up visits to monitor side effects and PSA levels for up to 2 years.",[389],"Prostate Cancer (Adenocarcinoma)",[391,392,393],"De-escalation","Radiotherapy","MR-Linac","2026-02-02",{"date":396,"type":53},"2026-02-06",{"date":398,"type":53},"2025-11-17",{"date":400,"type":22},"2028-12",{"name":59,"class":60},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":236,"minAge":409,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":91},"100543956","preoperative-accelerated-partial-breast-irradiation-in-patients-with-locally-recurrent-or-second-primary-breast-cancer-100543956","NCT06362616","Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer","PAPBI-3","Inclusion Criteria:\n\n* Female patients ≥ 51 years\n* Ipsilateral breast cancer; recurrence or second primary\n* Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)\n* Histologically proven estrogen receptor positive\n* HER2neu negative\n* In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm\n* Grade I or grade II (biopsy)\n* cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)\n* Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)\n* Interval since completion of local treatment of primary tumor \\> 12 months\n* Previous radiotherapy (whole breast or partial) of the ipsilateral breast\n* Repeat breast conserving surgery feasible\n* World Health Organization (WHO) performance ≤ 2\n* Written informed consent\n* The patient is legally competent\n\nExclusion Criteria:\n\n* ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor\n* Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area\n* Distant metastases and\u002For synchronous contralateral invasive or in situ carcinoma\n* Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)\n* ER negative subtype\n* Lymphovascular invasion in biopsy\n* Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months)\n* (Planned) oncoplastic surgery with major tissue displacement\n* Participation in another clinical trial that interferes with the locoregional treatment of this protocol.\n* It is expected that dosimetric constraints cannot be met, such as lung\u002Fheart constraints.\n* Patients with proven BRCA-mutations","51 Years",{"count":411,"type":22},31,[179],"This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.",[129],[416,417,418],"Recurrent breast cancer","Preoperative","Partial breast irradiation","2026-01-15",{"date":421,"type":53},"2026-01-20",{"date":423,"type":53},"2024-04-12",{"date":425,"type":22},"2027-04-11",{"name":59,"class":60},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":383,"minAge":19,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":91},"100493497","standard-moderately-hypofractionated-rt-vs-ultra-hypofractionated-focal-lesion-ablative-microboost-in-prostate-cancer-100493497","NCT05705921","Standard Moderately Hypofractionated RT vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer","Standard Moderately Hypofractionated Radiotherapy vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer, Hypo-FLAME 3.0","Inclusion Criteria:\n\n* Men ≥ 18 years with histologically confirmed prostate adenocarcinoma\n* No evidence of lymph node or distant metastases N0M0.\n* MRI visible tumor on mpMRI (PI-RADS v2 ≥ 4).\n* Intermediate- or high-risk PCa, defined as at least one of the following risk criteria (note; both the clinical T-stage and imaging T stage are noted in the CRF):\n\n  * clinical stage cT2c-T3a (UICC TNM 8th edition)\n  * Imaging stage T2c, T3a or T3b with less than 5 mm invasion in the seminal vesicles (as defined on mp MRI)\n  * ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)\n  * PSA ≥ 20 ng\u002FmL\n* World Health Organization (WHO) performance score ≤ 2\n* International prostate symptoms score (IPSS score) \\\u003C 15\n* PSA ≤ 30 ng\u002FmL\n* Prostate volume ≤ 90 cc on MRI\n* Ability to give written informed consent and willingness to return for follow-up\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy\n* TURP (transurethral prostate resection) within 6 months from start treatment\n* On-line image guidance based on either fiducial markers or high-quality CBCT or MRI according to local guidelines not feasible. For example: Unsafe to have gold fiducial marker implantation, if gold fiducial markers are used for image guidance. Distorted images on MR because of hip protheses prohibit accurate MR image guidance, if MR is used for image guidance.\n* Contraindications to MRI according to local hospital guidelines.",{"count":435,"type":22},484,[179],"EBRT is one of the standard treatment options for patients with localized PCA. Based on the outcome of randomized trials, moderately hypofractionated RT(19-25 fractions of 2.5-3.4Gy) is considered equivalent to conventional fractionated schemes with 35-39 fractions of 2Gy. A schedule of 20 fractions to a dose of 60-62Gy is adopted as standard of care for all risk-groups. Driven by the success of moderate hypofractionation, there is a strong trend towards extreme hypofractionation, also called SBRT, reducing the number of fractions even further. The schedule mostly used is 5 fractions of 7-7.25Gy. Its effectiveness, equivalence to standard EBRT schedules, has been demonstrated for low and favourable intermediate risk (IM) patients.\n\nFor unfavourable IM (here defined as IM with ISUP grade 3) and high-risk (HR) PCA the outcome of EBRT can be further improved by dose escalation. Because of dose-limiting toxicity, the maximal dose of EBRT for conventionally fractionated schemes was approximately 80Gy. Initially hypofractionation was considered as a potential way to escalate the biologically effective dose (BED) above 80Gy, however, this proved not to be the case. With hypofractionation, a saturation in dose effect seems to be present at a BED of 80Gy. Recently, the multi-centre phase III FLAME trial broke the '80Gy barrier' and showed that in mainly HR PCA patients, treated with a conventional fractionation schedule, focal boosting of the intraprostatic lesion to a total dose of 95Gy improves biochemical disease-free survival (bDFS). However, given the advantages of hypofractionation in terms of patient comfort and costs, the FLAME schedule is not ideal as the standard treatment.\n\nFor unfavourable IM and HR PCA patients the value of SBRT has not yet been established. The FLAME trial showed that higher than standard BED is a prerequisite for optimal bDFS. Furthermore, post SBRT biopsies results suggest a dose response relationship with better outcome of dose levels above 40Gy. Therefore, probably a higher than standard dose SBRT is necessary for these patients. A recent meta-analysis suggests diminishing results from increased fraction sizes in SBRT. So, the question remains whether dose escalation in SBRT will indeed improve treatment outcome.\n\nWith standard SBRT to the whole prostate, dose escalation is limited to 40Gy because of unacceptable toxicity. In line with FLAME, we conducted the Hypo-FLAME trial investigating focal dose escalation in SBRT. In the phase II Hypo-FLAME trial, 100 patients with IM or HR PCA were treated with SBRT 35Gy in 5 weekly fractions to the whole prostate with a focal boost up to 50Gy. The acute toxicity rates, the primary endpoint, were low and similar to standard SBRT indicating this schedule can be safely applied. Given this was a phase II trial, no conclusions on oncological outcome can be drawn.\n\nShortening of the overall treatment time (OTT) has been suggested to play a role in SBRT efficacy and 5 fractions delivered every other day this is internationally accepted as standard. We therefore initiated the phase II Hypo-FLAME 2.0 trial, investigating the feasibility of a reduction in the OTT of the Hypo-FLAME schedule from 29 to 15 days with acute toxicity as primary endpoint. The accrual of this trial is completed and a first analysis of the primary endpoint shows low toxicity figures, well in the range of what was expected. We expect to submit the analysis for publication by the end of 2022.\n\nAt present, it is unknown what the oncological efficacy of the Hypo-FLAME schedule is compared to the standard of care in unfavourable IM and HR prostate cancer. Therefore, we will conduct a Phase III multi-centre randomized trial, in which 484 patients with unfavourable IM or HR PCA will be randomized between:\n\n1. Standard treatment; moderately hypofractionated radiotherapy 62 Gy in 20 fractions of 3.1Gy\n2. Experimental treatment; SBRT 5x7Gy with an iso-toxic integrated focal boost up to 50 Gy (Hypo-FLAME).",[439],"Prostate Cancer",[366,441,442,443],"hypofractionation","prostate cancer","stereotactic radiotherapy",{"date":421,"type":53},{"date":446,"type":53},"2023-04-26",{"date":448,"type":22},"2032-01-01",{"name":59,"class":60},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":464,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":91},"100616834","phase-2-contrast-enhanced-ultrasound-for-sentinel-node-detection-100616834","NCT07310758","Contrast-enhanced Ultrasound for Sentinel Node Detection","Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer","Inclusion Criteria:\n\n* Aged 18 years or older\n* Patient has been diagnosed with cancer in the skin (melanoma), breast or head \\& neck (including melanoma of head and neck area)\n* In case of a melanoma: it should be located in the limbs or head and neck area\n* Scheduled for a surgical SN procedure at the NKI-AvL\n* Patient provides written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products\n* Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease",{"count":458,"type":22},91,[103,25],"This is a prospective single-center interventional non-inferiority study where subjects are participating for one day for patients 18 years or older with melanoma, breast cancer or head \\& neck cancer (including melanoma of head and neck area) and scheduled for a surgical SN procedure in the NKI-AvL without any contra-indication for Sonazoid contrast agent, such as an allergy to eggs or egg products. The primary objective is to assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Secondary objectives are the specificity of CEUS for intra-operative SN localization, the time required to localize the SNs using CEUS and intraoperative usability of the CEUS-system. The primary endpoint is the sensitivity of the CEUS SN localization method. The conventional gamma probe will be used as ground truth comparison.",[462,129,463],"Melanoma","Head & Neck Cancer",[465],"contrast-enhanced ultrasound","2025-12-16",{"date":468,"type":53},"2025-12-30",{"date":470,"type":53},"2025-09-18",{"date":472,"type":22},"2026-09-18",{"name":59,"class":60},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":383,"minAge":19,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":501},"100543287","phase-2-carboplatinpaclitaxel--pembrolizumab-for-locoregionally-advanced-penile-cancer-100543287","NCT06353906","Carboplatin\u002FPaclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer","A Phase 2 Clinical Study to Assess Efficacy of Induction Carboplatin\u002FPaclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer: PRIAM","PRIAM","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n2. Histologically confirmed diagnosis of squamous cell carcinoma of the penis.\n3. Patients have one of the following disease stages:\n\n   * cTxN2-3 or\n   * cTxN1 in case of central nodal necrosis and\u002For an irregular nodal border, or node \\>3cm, or\n   * Inguinal or pelvic lymph node recurrence that is potentially resectable. Any of the disease stages above, in combination with oligometastatic disease with a maximum of 2 distant metastases is allowed, as long as these metastases can be treated by resection or radiotherapy. This should be established in the multidisciplinary tumor board before enrolment.\n4. Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n5. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention.\n7. Have adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 10e9 \u002FL, platelets ≥100 10e9\u002FL; hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL; creatinine ≤1.5 × ULN OR GFR\\>30 ml\u002Fmin as per Cockcroft-Gault formula in patients with creatinine levels \\> 1.5x institutional ULN; total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; International normalized ratio (INR), prothrombin time (PT) OR activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Specimens must be collected within 14 days prior to the start of study intervention.\n\nExclusion Criteria:\n\n1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n2. Has received prior systemic anti-cancer therapy including investigational agents, or an investigational device, within 4 weeks prior to registration.\n3. Has received prior radiotherapy within 4 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.\n4. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n6. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n   Exceptions: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n7. Has known active or treated CNS metastases and\u002For carcinomatous meningitis.\n8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n9. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid). Patients with vitiligo, psoriasis or other mild skin disease can still be included.\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n11. Has an active infection requiring systemic therapy.\n12. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n13. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and\u002For Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Hepatitis B and C screening tests are not required unless a patient has a known history of HBV or HCV infection. Participants must have completed curative anti-viral therapy at least 6 months prior to randomization.\n14. Has not adequately recovered from major surgery or has ongoing surgical complications.\n15. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for the disease under study.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is expecting to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n19. Has had an allogenic tissue\u002Fsolid organ transplant",{"count":483,"type":22},27,[103],"This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis",[487,488,489,490,491,492],"Urologic Neoplasms","Urogenital Neoplasms","Male Urogenital Diseases","Penile Cancer","Penile Squamous Cell Carcinoma","Locally Advanced Penile Carcinoma","2025-12-05",{"date":495,"type":53},"2025-12-08",{"date":497,"type":53},"2024-08-13",{"date":499,"type":22},"2028-01-14",{"name":59,"class":60},2,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":325},"100614585","phase-3-transtympanic-sts-against-cisplatin-induced-snhl-the-sound-trial-100614585","NCT07281508","Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial","Transtympanic Sodium Thiosulfate to Prevent Cisplatin-related Hearing Loss A Randomized Controlled Multicenter Phase III Trial; The SOUND Trial","SOUND","Inclusion Criteria:\n\n* Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg\u002Fm2 given in a weekly schedule of 7 times 40 mg\u002Fm2 or a 3-weekly schedule of 3 times 100 mg\u002Fm2\n* Treatment with high-dose cisplatin (cumulative dose ≥ 200mg\u002Fm2) of maximum 7 cycles\n* Able and willing to give written informed consent;\n* WHO performance status of 0, 1 or 2;\n* Age older than 18 years.\n\nExclusion Criteria:\n\n* Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz).\n* Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)\n* A planned radiation dose of \\> 30 Gy to the cochlea (8);\n* Known hypersensitivity to STS-containing HYA gel formulation;\n* Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures;\n* Otologic pathology that hampers the transtympanically applied STS gel to diffuse through the round window, e.g. otosclerosis, a narrow ear canal, otitis media with effusion.",{"count":125,"type":22},[25],"The goal of this clinical trial is to learn if transtympanic sodium thiosulfate (STS) injections can prevent hearing loss caused by cisplatin chemotherapy in adults with head and neck cancer. The main question it aims to answer is:\n\nResearchers will compare the ear treated with STS gel to the untreated ear within the same patient to see if STS prevents hearing loss.\n\nParticipants will:\n\n1. Receive STS gel injections into the middle ear of one ear (randomized) within 3 hours before each cisplatin infusion (3-7 injections per patient).\n2. Undergo hearing tests at baseline and 2-4 months after the last cisplatin treatment.\n3. Complete questionnaires about hearing and tinnitus at baseline and 2-4 months after treatment.",[514],"Cisplatin-related Hearing Loss","2025-12-01",{"date":517,"type":53},"2025-12-15",{"date":519,"type":53},"2025-08-14",{"date":521,"type":22},"2030-03-23",{"name":59,"class":60},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":236,"minAge":19,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":91},"100537128","chemosensitivity-during-phases-of-the-menstrual-cycle-in-breast-cancer-patients-100537128","NCT06273800","Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients","Chemosense","Inclusion Criteria:\n\n* Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment.\n* Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. ,\n* Aged \\\u003C 60 years\n* Women having a (regular) physiological menstrual cycle\n* Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy\n* Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy)\n* Signed written informed consent\n\nExclusion Criteria:\n\n* current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as:\n* Oral contraception (OAC)\n* Hormonal intra-uterine device (IUD, Mirena)\n* No ovarian function suppression to preserve fertility\n* Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil\n* Currently pregnant and \u002F or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.\n\n  \\- active other malignancy\n* IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment","59 Years",{"count":125,"type":22},[179],"This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients",[129],[536,537,538,539],"Triple negative tumor","Stage I - III disease","Starting neo adjuvant treatment","Regular physiological menstrual cycle (premenopausal)","2025-11-21",{"date":542,"type":53},"2025-11-26",{"date":544,"type":53},"2025-10-14",{"date":546,"type":22},"2036-07-15",{"name":59,"class":60},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":91},"100514759","phase-2-basket-study-for-oligo-metastatic-breast-cancer-100514759","NCT05982678","Basket Study for Oligo-metastatic Breast Cancer","Basket Study for Oligo-metastatic Breast Cancer Part 1: Trastuzumab-deruxtecan for HER2-positive Oligo-metastatic Breast Cancer","ANISE","Inclusion Criteria:\n\n* Histologic proof of infiltrating HER2-positive breast cancer (as determined by IHC 3+ and\u002For amplification by ISH)\\[8\\]\n* Histologic or cytologic proof of breast cancer metastases (at least one lesion)\n* Histologic determination of level of ER-expression\n* Oligo-metastatic disease as determined by standard of care diagnostics. The number of total individual distant metastases is limited to five, either in one organ or in 2-5 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion. Pleuritis carcinomatosa, miliary spread of metastases (even within one organ), or peritoneal spread of metastases rules out oligo-metastatic disease and is not allowed. Initial staging by PET-CT (whole body) and MRI of breast and brain are mandatory, as is MRI liver or spine and pelvis in case of liver or bone metastases respectively.\n* In case of recurrent disease, a disease-free interval of 24 months.\n* Measurable disease according to RECIST1.1\n* Patients must be at least 18 years of age and be able to give written informed consent and comply with study procedures.\n* World Health Organization (WHO) performance status 0 or 1\n\nExclusion Criteria:\n\n* prior line of therapy for metastatic disease. Exceptions are endocrine therapy or radiation considered to be part of the curative treatment, within 3 months before enrolment\n* leptomeningeal disease or central nervous metastases\n* clinically relevant obstruction or compression of spinal cord, central nervous, gastro-intestinal or cardiovascular system, that cannot be alleviated before start of treatment.\n* other malignancy, unless treated with curative intention and a long-term survival probability of \\>95%, including in-situ or pre-malignant lesions.",{"count":557,"type":22},72,[103],"The study will include patients with HER2-positive breast cancer and 1- 3 distant metastatic lesions, all amenable for curative intervention. Patients will be stratified by prior therapy and ER expression. In the initial baskets patients with be treated with trastuzumab-deruxtecan.\n\nPatients are treated with T-DXd 5.4mg\u002Fkg on a three weekly (21 day) basis, with the goal of 16 cycles leading to a treatment period of year, including local treatment. The first 8 cycles of T-DXd are administered neo-adjuvant, and 8 cycles adjuvant, after completion of local treatment.\n\nThe proposed M22BOL trial is based on an important knowledge gap for regarding breast cancer patients with 'oligo-metastatic' disease who are usually not included in clinical trials for patients with metastatic disease since loco-regional treatments (radiation, surgery) with curative intent is not allowed in clinical trials for metastatic breast cancer. Moreover, neo-adjuvant trial protocols for early breast cancer exclude patients with distant metastases that can be treated with curative intent. This basket trial evaluates T-DXd for oligo-metastatic breast cancer with the goal to induce deep responses and subsequently long-lasting disease remissions and potentially cure.",[561],"HER2-positive Breast Cancer",[563],"Oligometastatic disease (max 3 lesions)",{"date":542,"type":53},{"date":566,"type":53},"2024-05-02",{"date":568,"type":22},"2034-10-01",{"name":59,"class":60},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":591,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":601},"100534368","phase-2-stage-ii-iiia-urothelial-cancer-randomizing-pre-operative-nivolumab-with-or-without-relatlimab-100534368","NCT06237920","Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","TURANDORELA","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥ 18 years\n* Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.\n* Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.\n* Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria\n* World Health Organization (WHO) performance Status 0 or 1.\n* Urothelial cancer is the dominant histology (\\>50%). Any component of small cell or adenocarcinoma is not allowed.\n* Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Platelets ≥100 x109\u002FL, Hemoglobin ≥5.5 mmol\u002FL, GFR\\>30 ml\u002Fmin, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN\n* Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.\n* Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)\n\nExclusion Criteria:\n\n* Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.\n* Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).\n* Previous intravenous systemic therapy or radiotherapy for UC.\n* Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.\n* Prior CTLA-4, LAG3 or PD-1\u002FPD-L1-targeting immunotherapy.\n* Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n* HIV-positive patients are eligible if the following applies:\n* No AIDS defining opportunistic infection within the last year and a current CD4 count \\>350 cells\u002FuL.\n* Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study\n* CD4 counts and viral load are monitored per standard of care by a local health care provider\n* In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.\n* Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.\n* Use of other investigational drugs before study drug administration.\n* Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated \\>10%). Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n* Pregnant and lactating female patients.\n* Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n* Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina.",{"count":579,"type":22},90,[103],"This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment",[487,488,583,584,585,586,587,588,489,589,590],"Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Urinary Bladder Diseases","Urinary Bladder Neoplasm","Antineoplastics Toxicity",[592,304],"Nivolumab","2025-09-01",{"date":595,"type":53},"2025-09-03",{"date":597,"type":53},"2024-02-19",{"date":599,"type":22},"2028-08-01",{"name":59,"class":60},9,{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":91},"100595508","functional-liver-after-sbrt-100595508","NCT07033364","Functional Liver After SBRT","Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy","FAFOR","Inclusion Criteria:\n\n* Patient treated for a liver metastasis with SBRT with treatment prescription of 3 x 20 Gy\n* Able to provide informed consent prior to any study specific procedure\n\nExclusion Criteria:\n\n* WHO \\> 2\n* Pregnancy\n* Prior radiation therapy of the liver\n* Lactation, unable to substitute for 24 hours\n* Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions\n\nExclusion criteria for HEBIS scan:\n\n* GFR \\\u003C 30 ml\u002Fmin\u002F1.73m2\n* \\\u003C 2 weeks after antiviral eradication therapy for hepatitis C\n* Bilirubine \\> 30 µmol\u002Fl\n* Relative contra-indications (possibly affecting liver function): opiates, barbiturates, somatostatine, colestyramine, rifampicine, atropine",{"count":611,"type":22},15,"In this study, the investigators aim to determine the dose-effect relationship between radiation dose and liver function by performing a hepatobiliary scintigraphy (HEBIS) before and after stereotactic body radiotherapy (SBRT) for patients with liver metastases. HEBIS is a nuclear imaging technique to quantitatively assess liver function. It better predicts the risk of postsurgical liver failure compared to volumetry alone. To prevent liver failure after SBRT, current clinical dose constraints require that ≥ 700 ml of normal liver should receive less than 15 Gy in 3 fractions. The exact local dose-effect relation is however unknown. Doses below 15 Gy are still damaging, while liver tissue receiving doses above 15 Gy will retain some function. By associating the 3D radiation dose distribution with the HEBIS scan, the investigators can evaluate the impact of radiation dose on liver function for different dose levels in liver (sub)volumes. This analysis will refine existing dose-effect relationships, enabling more tailored treatment of liver metastases in the future. Ten to fifteen patients will be included to assess functional liver imaging using HEBIS before their treatment and 3 to 4 months after their treatment.",[614],"Liver Metastases",[616,617,618,619,366,620,621,622,623,624],"liver function test","functional liver imaging","hepatobiliary scintigraphy","dose effect relationship","SBRT","nuclear medicine","liver function","HEBIS","HIDA","2025-08-19",{"date":627,"type":53},"2025-08-20",{"date":629,"type":53},"2025-07-21",{"date":631,"type":22},"2026-07-31",{"name":59,"class":60},{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":91},"100559787","earlier-detection-and-optimization-of-treatment-and-prognosis-for-patients-with-early-onset-colorectal-cancer-100559787","NCT06568679","Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer","Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study","BIO-EOCRC","Inclusion Criteria:\n\n* Patients with locoregional or metastatic colorectal cancer (CRC)\n* Histologically proven CRC\n* Age 18 - 49 years at time of first CRC diagnosis\n* Able to understand the informed consent form\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Mentally incompetent patients based on the opinion of treating physician\n* Inability to understand the Dutch language","49 Years",{"count":643,"type":22},300,"The study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during \u002F after treatment of early-onset colorectal cancer (EOCRC) and to inform on treatment and survival outcomes of EOCRC patients.",[646],"Early-onset Colorectal Cancer","2025-07-31",{"date":649,"type":53},"2025-08-05",{"date":651,"type":53},"2025-01-27",{"date":653,"type":22},"2038-12-01",{"name":59,"class":60},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":91},"100569248","feasibility-of-cbct-guided-online-adaptive-radiotherapy-fascinate-100569248","NCT06691776","Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE)","FASCINATE: FeASibility of Cbct-guIded oNline Adaptive radioThErapy","FASCINATE","General Inclusion Criteria:\n\n* Patient, age ≥ 18 years, referred for a radiotherapy schedule as described in one of the cohorts.\n* WHO performance score 0-3.\n* Provision of signed, written and dated IC prior to any study specific procedures.\n\nSpecific inclusion criteria for prostate cohort:\n\n* Accepted for radiotherapy of the prostate and pelvic lymph node areas.\n* Pathology-proven prostate cancer.\n* cT1-4\n* cN1 on PSMA-PET\u002FCT or pN1 based on node biopsy, SN-procedure or lymph node dissection.\n* cM0 on PSMA-PET\u002FCT (except for patients with M1a disease who are still considered for radiotherapy of the prostate and pelvic lymph node areas).\n\nSpecific inclusion criteria for cervical cohort:\n\n* Accepted for radiotherapy of the cervix (with or without chemotherapy) and pelvic lymph node areas (25 fractions, followed by either a brachytherapy or external radiotherapy boost).\n* Pathology-proven cervical cancer.\n* FIGO IIA2, IB3 and \\> 6cm, IIB-IVA or N+. Or other stage and unfit for surgery.\n* cM0 or cM1 and accepted for locoregional radical (chemo)radiation in 25 fractions.\n\nSpecific inclusion criteria for bladder cohort:\n\n* Accepted for radiotherapy of the bladder, either to the entire bladder or with a boost to the tumor area (with or without chemotherapy).\n* Pathology-proven bladder carcinoma.\n* cT1-4\n* cN0 or cN1-2 after induction treatment (with or without lymph node dissection)\n\nSpecific inclusion criteria for lung cohort:\n\n* Accepted for radiotherapy for lung cancer with lymph node metastases (with or without chemotherapy).\n* Non-small cell lung cancer (either pathology proven or enough clinical suspicion to warrant radiotherapy to primary tumor and pathologic lymph nodes.\n* cT1-4 and cN1-3.\n* M0 or m1 and accepted for radical radiotherapy in 24 fractions of 1 or more lymph node metastases and a primary tumor and\u002For pulmonary metastases.\n\nSpecific inclusion criteria for head and neck cohort:\n\n* Accepted for radiotherapy for head and neck cancer (with or without chemotherapy).\n* Pathology-proven carcinoma of the pharynx, oral cavity or larynx.\n* cT1-4\n* cN0-3 and indication for elective neck radiation (either 1 or 2 sides).\n* cM0\n\nGeneral Exclusion Criteria:\n\n* Patients who are pregnant.\n\nSpecific for prostate cohort:\n\n* Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).\n* Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician).\n\nSpecific for cervical cohort:\n\n\\- Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).\n\nSpecific for bladder cohort:\n\n* Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).\n* Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician).\n\nSpecific for lung cohort:\n\n\\- Severe pulmonary complaints that could make the longer treatment time problematic (according to judgement of treating physician).\n\nSpecific for head and neck cohort:\n\n* Severe complaints that could make the longer treatment time problematic (according to judgement of treating physician).\n* Pulmonary fibrosis",{"count":125,"type":22},[179],"The accuracy of radiotherapy can be increased by correcting for geometric uncertainties and changes between radiotherapy fractions. These corrections are currently done with online adaptive treatment on a specialized linear accelerator (linac) for a small subset of patients. However, patients currently treated on a standard linac could also benefit from online adaptive radiotherapy. The objective is to determine the feasibility of online CBCT-guided adaptive radiation therapy on a standard Elekta linac.",[439,667,668,669,670],"Cervical Cancer","Bladder Cancer","Lung Cancer","Head and Neck Cancer","2025-07-29",{"date":673,"type":53},"2025-08-01",{"date":675,"type":53},"2023-08-29",{"date":677,"type":22},"2028-12-01",{"name":59,"class":60},""]