[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-toxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-toxicity":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,61,90,131,190,219,247,260,285,325,364,391,421,446,469,489,521,545,565,589,613,638,666],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"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":20,"type":21},408,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33],"Radiation Necrosis","High Grade Glioma (III or IV)","Brain Metastasases","Radiation Toxicity","Radiation Effect","Radiation Injury","Radiation Injuries",[35,36,37,38,39,40,41,42,43,44,45,46,47],"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":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":52},"2025-06-19",{"date":56,"type":21},"2030-07",{"name":58,"class":59},"The Netherlands Cancer Institute","OTHER",6,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100416274","phase-1-the-effects-of-scfa-supplementation-in-subjects-receiving-abdominopelvic-rt-a-randomized-controlled-study-100416274","NCT04700527","The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study","LCCC2032: The Effects of Short Chain Fatty Acid Supplementation on the Quality of Life and Treatment-related Toxicities in Subjects Receiving Abdominopelvic Radiotherapy: A Randomized Controlled Study","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and\u002For surgical resection (archival tissue) and serial blood draws will be required for enrollment.\n* ≥ 18 years of age on day of signing informed consent.\n* ECOG performance score ≤ 2\n* Subjects with histological or cytological evidence\u002Fconfirmation of GI, urologic or gynecologic malignancy that will be treated with minimum dose of 40Gy (equivalent dose in 2Gy per fraction or EQD2) via 3D conformal fields or IMRT to abdomen or pelvis (multimodality treatment with surgery, chemotherapy is permissible)\n* Subjects may have had prior chemotherapy or surgery.\n* Subjects deemed healthy for study inclusion by the treating physician based on the laboratory values at screening and general health status.\n* Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline.\n* Females of childbearing potential must have a negative urine pregnancy test within 14 days prior to simulation. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.\n* Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 14 or 28 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \\\u003C 1% failure rate for protection from pregnancy in the product label.\n* Male subjects with female partners of childbearing potential must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 14-28 days after the last dose of study therapy.\n* Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Prior abdominopelvic RT\n* History of inflammatory bowel disease or GI motility disorder\n* Grade 2 or higher diarrhea at baseline unless deemed by the investigator to be caused by laxatives prescribed for symptomatic partial obstruction\n* Concurrent use of histone deacetylase inhibitors (vorinostat)\n* Baseline hypernatremia defined as serum sodium concentration \\>145 mEg\u002FL\n* Creatinine clearance \\\u003C 50 mL\u002Fmin\n* Congestive heart failure\n* On a salt restricted diet for medical indications\n* Severe nut allergy\n* Active infection requiring systemic therapy.\n* Active central nervous system (CNS) metastases\n* Treatment with any investigational drug other than the drugs in this study and subjects may not be on another clinical trial.\n* Subject is receiving prohibited medications or treatments as listed in section 5.6 of the protocol that cannot be discontinued\u002Freplaced by an alternative therapy.",{"count":69,"type":21},122,[71,72],"PHASE1","PHASE2","The purpose of this study is to assess and compare GI toxicity from RT between subjects who receive therapeutic SCFA and those who receive placebo, in hopes of identifying a safe, low-cost therapeutic to reduce GI toxicity from therapeutic or environmental radiation.",[75,30],"Toxicity",[77,78,79],"GI cancer","Urinary cancer","Gynecological Cancer","2026-06-01",{"date":82,"type":52},"2026-06-03",{"date":84,"type":52},"2023-12-15",{"date":86,"type":21},"2031-05",{"name":88,"class":59},"UNC Lineberger Comprehensive Cancer Center",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":112,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":89},"100488116","effect-of-a-novel-topical-composition-on-the-incidence-of-severe-oral-mucositis-in-head--neck-cancer-radiated-patients-and-quality-of-life-assessed-by-proms-100488116","NCT05635929","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.","STOPOMP","Inclusion Criteria:\n\nAcute Phase\n\n* Patients diagnosed with Head \\& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nChronic Phase\n\n* Patients who have completed radiotherapy treatment at least 6 months before study enrollement.\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nExclusion Criteria:\n\nAcute Phase\n\n* Patients who are unable to properly use the products.\n* Patients who do not consent to participate in the study.\n* Patients who were being treated for another type of cancer.\n\nChronic Phase\n\n* Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.\n* Patients who do not consent to participate in the study.",{"count":99,"type":21},63,[101],"NA","The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \\& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \\& Neck cancer radiated patients.",[104,105,106,107,108,109,30,110,111],"Oral Mucositis","Quality of Life","Mucositis","Pain","Speech","Saliva","Chemotherapeutic Toxicity","Head and Neck Cancer",[104,113,114,107,115,116,117,118,119,111,120],"Cancer Therapy Toxic Effect","Cancer Support","Ulcers","Treatment Interruptions","Oral Mucosa","Radiotherapy","Chemotherapy","Severe Oral Mucositis","2026-04-10",{"date":123,"type":52},"2026-04-15",{"date":125,"type":52},"2022-10-11",{"date":127,"type":21},"2027-03",{"name":129,"class":130},"Mucosa Innovations, S.L.","INDUSTRY",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":141,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":140,"type":21},8000,"2 Years","OBSERVATIONAL","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[145,146,147,148,149,150,151,152,153,154,30,105,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,111,170,171,172,173,174,175,176,177,178,179],"Oncology","Breast Cancer","Prostate Cancer","Gynecologic Cancer","Brain Tumor","Brain Cancer","Gynecologic Tumor","Prostate Tumor","Prostate Neoplasm","Breast Tumor","Rectal Cancer","Rectal Tumor","Rectal Neoplasms","Lung Cancer","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Cancer","Pancreatic Tumor","Pancreatic Neoplasms","Head and Neck Neoplasms","Head and Neck Tumor","Tumor","Neoplasms","Bladder Cancer","Bladder Neoplasm","Liver Cancer","Liver Neoplasms","Liver Metastases","Oligometastases","2026-03-03",{"date":182,"type":52},"2026-03-05",{"date":184,"type":52},"2019-02-01",{"date":186,"type":21},"2030-08-01",{"name":188,"class":59},"UMC Utrecht",18,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":198,"targetDuration":200,"studyType":142,"phases":4,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":89},"100589104","curatively-intended-thoracic-reirradiation-100589104","NCT06950073","Curatively Intended Thoracic Reirradiation","CUratively Intended Thoracic REirradiation: An Observational Study of High-dose Reirradiation of Thoracic Tumours: A Multicentre Prospective Registration Protocol","CureLung","Inclusion Criteria:\n\n* Radiotherapy of thoracic lesion(s) (loco-regional lung cancer recurrence, new primary lung cancer, or solitary oligo metastasis) with the aim of long-term local control.\n* Reirradiation type 1 or type 2, i.e. previous radiotherapy to the thorax as per ESTRO-EORTC consensus definition of reirradiation \\[Andratschke 2022\\]. For the sake of this study, multiple treatments to the lungs will be classified as type 2 reirradiation.\n* Verification of malignancy based on biopsy. If no biopsy is available, the decision of reirradiation should be agreed upon in a multidisciplinary conference.\n* Available digital dose plan(s) from former radiotherapy course(s) (DICOM files) - note that multiple re-treatments are allowed.\n* Adequate lung function to tolerate treatment, at the discretion of the treating physician.\n* Ability to complete a radiotherapy course with the aim of local control.\n* ECOG Performance status 0-2.\n* Estimated life expectancy ≥ 6 months\n* Age ≥18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled other malignancy.\n* The primary and the reirradiation treatment may not be quasi-simultaneous (i.e. the two treatments should be planned independently)\n* Pregnancy\n* Radiotherapy to a minimum CTV mean dose of 45 Gy for SCLC and 50 Gy for NSCLC and oligometastatic lesions. Treatment schedule according to local protocols and treating physician preference.",{"count":199,"type":21},500,"10 Years","The number of long-term lung cancer (LC) survivors increases, however many patients are diagnosed with recurrent or new thoracic cancers. High-dose reirradiation (reRT) is promising but associated with high severe toxicity rates. Existing studies are small lacking high-quality data, with no clear correlation between toxicity risk and delivered radiotherapy (RT) dose.\n\nThis Danish multicentre prospective cohort study aims to provide a framework for collecting radiotherapy-related toxicity data, loco-regional control, and overall survival data for patients with thoracic cancer undergoing reirradiation; with the ultimate aim of providing safe reirradiation to more patients.\n\nAs a secondary aim, guidelines for dose accumulation and provisional constraints for the organs at risk will be used to establish a uniform treatment strategy for reirradiation.\n\nThe CURE Lung trial will provide high-impact, globally missing data. This project will ensure full utilization of and learning from the trial, adding SDM, PROMs, and modality referral to the trial. It will model the correlation between toxicity burden and doses, enabling individualized reRT with optimized dose prescription based on toxicity risk and patient preferences, and assisting in the decision-making on the prescription dose and optimal modality. This will ensure safe reRT for the increasing number of long-term LC survivors.",[203,30,145,158,204],"Radiotherapy Side Effect","Thoracic Cancer",[206,207,208,209,158,145,30],"Reirradiation","Aarhus","Denmark","Thoracic cancer","2026-03-02",{"date":212,"type":52},"2026-03-04",{"date":214,"type":52},"2025-10-10",{"date":216,"type":21},"2035-05-01",{"name":218,"class":59},"University of Aarhus",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":225,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":234,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100520670","pre-rehabilitation-for-female-patients-undergoing-pelvic-radiotherapy-100520670","NCT06059586","Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy","Inclusion Criteria:\n\n1. Female\n2. ≥ 18 years old at the time of informed consent\n3. Ability to provide written informed consent and HIPAA authorization\n4. Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer\n5. Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion\n\nNotes:\n\n* Can have prior and\u002For current modalities of treatment to address diagnosis including surgery and chemotherapy\n* Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North\u002FSchwarz Cancer Center\n\nExclusion Criteria:\n\n1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and\u002For interfere with follow-up.\n2. Not a candidate for curative radiation therapy per radiation oncologist's discretion\n3. Prior radiation therapy to the pelvis\n4. Women who are pregnant or nursing","FEMALE",{"count":227,"type":21},20,[101],"The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.",[231,232,233,30],"Dyspareunia","Pelvic Pain","Sexual Dysfunction",[235,236],"vaginal dilator","pelvic health physical therapy","2026-02-25",{"date":239,"type":52},"2026-02-27",{"date":241,"type":52},"2024-01-16",{"date":243,"type":21},"2027-06",{"name":245,"class":59},"Indiana University",3,{"id":248,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":25,"conditions":252,"keywords":253,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":257,"leadSponsor":258,"locationsCount":259},"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":20,"type":21},[24],[27,28,29,30,31,32,33],[35,36,37,38,39,40,41,42,43,44,45,46,47],"2026-02-24",{"date":237,"type":52},{"date":54,"type":52},{"date":56,"type":21},{"name":58,"class":59},5,{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":267,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":89},"100480028","early-phase-1-a-study-to-determine-the-preferred-dose-of-the-drug-lisinopril-for-preventing-urinary-toxicity-following-radiotherapy-for-prostate-cancer-100480028","NCT05530655","A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer","A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer","Inclusion Criteria:\n\n* Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates for curative-intent external beam radiation (with or without androgen deprivation therapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology. Radiotherapy may be either primary, adjuvant or salvage. It may be part of combined treatment with androgen deprivation therapy.\n* Be stage M0 based on the standard of care staging imaging\n* Be able to read English\n* Have the psychological ability and general health that permits completion of the study requirements and required follow up\n* Be ≥18 and \\\u003C 70 years of age\n* Have ECOG performance status of 0 to 2 within 180 days prior to enrollment\n* Have adequate renal function with creatinine clearance \\> 30 mL\u002Fmin within 30 days prior to registration\n* Have hematologic and hepatic function deemed adequate for planned treatment by the treating investigator within 90 days prior to registration, including:\n* hemoglobin ≥9.0 g\u002FdL, independent of transfusion and\u002For growth factors\n* platelet count ≥100,000\u002FµL independent of transfusion and\u002For growth factors\n* Have a baseline systolic blood pressure of \\>130.\n\nExclusion Criteria:\n\n* Have received prior pelvic radiotherapy\n* Be taking lisinopril or other RAS modifying drug within two months prior to registration\n* Have had a prior allergic reaction to lisinopril","MALE","70 Years",{"count":270,"type":21},30,[272],"EARLY_PHASE1","This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.",[147,30,275],"Urinary Complication","2026-01-09",{"date":278,"type":52},"2026-01-13",{"date":280,"type":52},"2024-02-20",{"date":282,"type":21},"2028-01-01",{"name":284,"class":59},"University of Rochester",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":295,"studyType":142,"phases":4,"briefSummary":296,"conditions":297,"keywords":302,"overallStatus":315,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":89},"100617994","patients-referred-to-the-chronic-pain-unit-for-palliative-treatment-with-ozone-therapy-between-2026-and-2029-100617994","NCT07325851","Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029.","Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029. Prospective Study EPOOzo-2.","EPOOzo-2","Inclusion Criteria:\n\n* 1\\. Adults ≥ 18 years old.\n* 2\\. Patients referred to the Chronic Pain Unit of the Dr. Negrín University Hospital for symptomatic\u002Fpalliative treatment with ozone therapy because conventional treatment does not exist, has failed, has offered insufficient results, or is associated with high risk\u002Fmorbidity.\n* 3\\. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.\n* 4\\. Patients have no contraindications for ozone treatment.\n* 5\\. Patients must sign the specific Informed Consent for this study and for the ozone treatment.\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years old.\n* 2\\. Psychiatric illness or social situations that would limit compliance with study requirements.\n\nContraindication or disability to attend scheduled treatments.\n\n* 3\\. Contraindication or disability to attend scheduled treatments.\n* 4\\. Uncontrolled clinical conditions (e.g., severe heart failure, massive hemorrhage, status epilepticus).\n* 5\\. Life expectancy \\\u003C 6 months.\n* 6\\. Known allergy to ozone.\n* 7\\. Hemochromatosis (for systemic ozone treatment).\n* 8\\. Pregnancy (for systemic ozone treatment).\n* 9\\. Significant Glucose-6-Phosphate Dehydrogenase deficiency (Favism) (for systemic ozone treatment).\n* 10\\. Patients who do not meet the inclusion criteria.",{"count":294,"type":21},120,"40 Weeks","The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms who have been referred to the Dr. Negrín University Hospital Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between January 2026 and December 2029. Additionally, the study aims to evaluate several specific symptoms, hyperspectral and thermal images, non-invasive clinical parameters related to the Autonomic Nervous System (such as heart rate variability, electrochemical skin conductance, and vibration perception thresholds), oxidative stress and inflammatory parameters, and gut microbiota composition.",[298,30,299,300,301],"Chemotherapy-Induced Peripheral Neuropathy","Chronic Pain","Delayed Wound Healing","Refractory Symptoms",[303,304,305,306,307,308,309,310,311,312,313,314],"Ozone Therapy","Health-related quality of life","Chemotherapy-induced Peripheral Neuropathy","Radiation-induced toxicity","Hyperspectral imaging","Infrared imaging","Heart Rate Variability","Sudoscan","Vibrometry","Oxidative stress","Gut Microbiota","Anxiety and Depression","NOT_YET_RECRUITING","2025-12-23",{"date":318,"type":52},"2026-01-08",{"date":320,"type":21},"2026-01-14",{"date":322,"type":21},"2030-06-30",{"name":324,"class":59},"Bernardino Clavo, MD, PhD",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":225,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":335,"studyType":142,"phases":4,"briefSummary":336,"conditions":337,"keywords":346,"overallStatus":315,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.",{"count":334,"type":21},38,"4 Months","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[338,30,339,340,341,342,343,344,105,345],"Pelvic Toxicity","Chemotherapy Toxicity","Gynecological Tumors","Radiation Proctitis","Radiation Cystitis","Vaginal Mucositis","Vulvar Mucositis","Dysbiosis",[347,348,349,350,118,119,351,352,353,354,345],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","2025-12-16",{"date":357,"type":52},"2025-12-22",{"date":359,"type":21},"2026-01-15",{"date":361,"type":21},"2028-03-31",{"name":324,"class":59},2,{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":374,"studyType":142,"phases":4,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":89},"100471350","patients-referred-to-the-chronic-pain-unit-for-palliative-treatment-with-ozone-therapy-between-2022-and-2025-100471350","NCT05417737","Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025","Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025. (EPOOzo)","EPOOzo","Inclusion Criteria:\n\n1. Adults \\> = 18 years old.\n2. Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic\u002Fpalliative treatment with ozone therapy because conventional treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.\n3. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.\n4. Patients have no contraindications for ozone treatment.\n5. Patients have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years old.\n2. Psychiatric illness or social situations that would limit compliance with study requirements.\n3. Those who are incapable to fill in the scales used to measure variables.\n4. Hemodynamically or clinically unstable patients or uncontrolled severe illness.\n5. Uncontrolled cancer disease requiring chemotherapy treatment.\n6. Life expectancy \\\u003C 6 months\n7. Contraindication or disability or to attend scheduled treatments.\n8. Known allergy to ozone.\n9. Pregnancy at the time of enrollment (for systemic ozone therapy). 10 Hemochromatosis (for systemic ozone therapy).\n\n11\\. Known significant glucose-6-phosphate dehydrogenase deficiency (favism, acute hemolytic anemia) (for systemic ozone therapy).\n\n12\\. Patients who do not meet all the inclusion criteria",{"count":373,"type":21},105,"28 Weeks","The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms, who have been referred to the HUGCDN Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between June-2022 and December-2025",[30,110,305,300,299,377],"Refractory Pain",[305,306,379,380,381,304,314,349,382],"Cancer-treatment side effects","Delayed wound healing","Chronic pain","Refractory pain","2025-08-25",{"date":385,"type":52},"2025-09-02",{"date":387,"type":52},"2022-06-15",{"date":389,"type":21},"2026-06-30",{"name":324,"class":59},{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":398,"targetDuration":400,"studyType":142,"phases":4,"briefSummary":401,"conditions":402,"keywords":406,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":89},"100454877","longitudinal-registry-including-patients-treated-with-heavy-particles-100454877","NCT05203250","Longitudinal Registry Including Patients Treated With Heavy Particles","CNAO REgistry triAL - REGAL","Inclusion Criteria:\n\n* Patients treated with heavy particles at Fondazione CNAO, Pavia\n* Patients who have the ability to understand and be willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients or legal guardians who are unable to understand informed consent document",{"count":399,"type":21},3000,"50 Years","The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.\n\nBy keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.",[403,145,404,203,30,405],"Cancer","Radiation Exposure","Rare Disease",[407,145,403,118,408,409,410,411],"Hadrontherapy","Protons","Carbon Ions","Heavy ions","Rare cancer","2025-08-01",{"date":414,"type":52},"2025-08-06",{"date":416,"type":52},"2021-06-04",{"date":418,"type":21},"2071-06-04",{"name":420,"class":59},"CNAO National Center of Oncological Hadrontherapy",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":17,"minAge":429,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":246},"100518912","neurocognitive-impact-of-different-irradiation-modalities-for-patients-with-grade-i-ii-skull-base-meningioma-100518912","NCT06036706","Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:","Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study","CANCER-COG","Patients:\n\nInclusion Criteria:\n\n* Benign meningioma (grade I), or atypical meningioma (grade II)\n* Histologic proven of benign meningioma, atypical meningioma or unequivocal radiological diagnosis of skull base meningioma if biopsy is recused.\n* Indication of irradiation validated by a multidisciplinary meeting\n* Age \\>20 years and \\\u003C65 years\n* Expected overall survival \\>10 years\n* Adjuvant or exclusive irradiation is allowed.\n* Signed informed consent form\n* WHO Performance status equal to 0 or 1\n* Patient affiliated to the French social health insurance\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol\n\nExclusion Criteria:\n\n* Patient with mutation in a known predisposition gene (NF-2, SMARCE-1).\n* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia.\n* Other localization than skull base meningioma\n* Histology\u002Fradiological features rather different than grade I-II meningioma\n* Histologic proven grade III meningioma\n* Uncontrolled epilepsy\n* Contraindication to MRI\n* Patient with a history of brain irradiation.\n* Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)\n* Pregnant\u002Fbreastfeeding woman\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study\n* Participation in a therapeutic trial evaluating a radiotherapy schedule or a new drug or combination for less than 30 days\n* Patient deprived of freedom or under guardianship\n* Hypersensibility to Gadolinium\n\nParticipants free of brain disease or cancer history:\n\nInclusion Criteria:\n\n* Subject without any history of neurological disease (cerebral stroke, epilepsy, Intra cranial Neurosurgery procedure, meningioma, pituitary adenoma, Parkinson disease,Dementia…) or absence of personality disorders and progressive psychiatric pathology\n* Age \\>20 years and \\\u003C65 years\n* Signed informed consent form\n* WHO Performance status equal to 0 or 1\n* Subject affiliated to the French social health insurance\n* Subject whose neuropsychological abilities allow to follow the requirements of the protocol\n* No major cognitive disorder that may compromise the realization of cognitive evaluations, defined as a MoCA score in accordance with the threshold depending on age and educational level according to the GRECOGVASC normative data\n\nNon-inclusion criteria\n\n* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia\n* History of epilepsy with antiepileptic drug\n* Subject with a history of brain irradiation\n* Subject with a history of cancer in the last five years (Excluding skin baso-cellular carcinoma)\n* Pregnant\u002Fbreastfeeding woman\n* Any geographical conditions, social and associated psychopathology that may compromise the subject's ability to participate in the study\n* Participation in a therapeutic trial - Subject deprived of freedom or under guardianship","20 Years","65 Years",{"count":432,"type":21},108,[101],"For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.",[436,30],"Meningioma","2025-06-18",{"date":439,"type":52},"2025-06-24",{"date":441,"type":52},"2023-09-13",{"date":443,"type":21},"2039-06",{"name":445,"class":59},"Centre Francois Baclesse",{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":89},"100540063","phase-2-the-clinical-study-of-post-operative-proton-radiotherapy-for-thymus-tumor-100540063","NCT06311968","The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor","Prospective Phase II Clinical Study of R0\u002FR1 Post-operative Proton Radiation Therapy for Thymus Epithelial Malignancies","Inclusion Criteria:\n\n* Patients with stage II-III (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiation therapy, who have undergone radical surgery and have a definite pathological diagnosis, and undergone surgery for R0 (no microscopic residual disease) or R1 (microscopic residual disease) resection, and have indication of postoperative radiation therapy.\n* Sign informed consent.\n* Between the ages of 18 and 70.\n* ECOG general status score of 0-2.\n* The expected survival is at least 6 months.\n* Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109\u002FL, platelet count ≥80 x 109\u002FL, hemoglobin ≥9 g\u002FdL 2). Lung function: FEV1\\>25%, DLCO\\>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \\\u003C1.5 times the upper limit of normal value, and AST, ALT\\\u003C2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml \u002Fmin, and urinary protein \\\u003C2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.\n\nExclusion Criteria:\n\n* Complicated with other malignant tumors that have not been controlled.\n* Have large quantity of pleural or pericardial effusion.\n* Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.\n* Chest radiation therapy or radioactive particle implantation history.\n* Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.\n* HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.\n* A history of mental illness may hinder the completion of treatment.\n* With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.\n* Other circumstances that the physician considers inappropriate to participate in clinical study.",{"count":454,"type":21},55,[72],"To observe the efficacy and toxicities of post-operative (R0\u002FR1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.",[458,459,30],"Thymus Epithelial Tumor","Proton Radiotherapy","2025-06-10",{"date":462,"type":52},"2025-06-13",{"date":464,"type":52},"2024-05-06",{"date":466,"type":21},"2027-02-28",{"name":468,"class":59},"Jian Chen",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":89},"100556943","precision-radiotherapy-for-tumours-using-magnetic-resonance-guided-linear-accelerator-mr-linac-100556943","NCT06531681","Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)","The Second Affiliated Hospital of Hainan Medical University","Inclusion Criteria:\n\n* Patients are undergoing or have undergone imaging or treatment at the MR linac;\n* Age 18-75 years, male or female;\n* ECOG score 0-2, life expectancy \\> 6 months;\n* Patients provide written informed consent.\n\nExclusion Criteria:\n\n* Contraindications to MRI, such as claustrophobia and metallic or electronic implants incompatible with MRI;\n* The presence of severe comorbidities that, in the opinion of the investigator, · preclude the toleration or completion of radiotherapy;\n* Acute inflammatory disease requiring systemic therapy;\n* The presence of active infectious disease;\n* Pregnant women, nursing mothers, and patients planning to have children during the study period.","75 Years",{"count":399,"type":21},"Aim to observe the application of MR-Linac for precision radiotherapy of tumours, analyse its therapeutic effect, toxic and side effects,Characteristics of dosimetric parameters etc.",[480,145,30,105],"Overall Response Rate","2025-02-11",{"date":483,"type":52},"2025-02-13",{"date":485,"type":52},"2023-08-19",{"date":487,"type":21},"2028-12-31",{"name":474,"class":59},{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":497,"enrollmentInfo":498,"targetDuration":500,"studyType":142,"phases":4,"briefSummary":501,"conditions":502,"keywords":510,"overallStatus":315,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":4},"100559566","a-maajor-radiation-based-pci-study-in-stemi-and-nstemi-100559566","NCT06565793","A MAajor RAdiation-based PCI Study in STEMI and NSTEMI","The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.","MARAA","Inclusion Criteria:\n\n* The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.\n\nExclusion Criteria:\n\n\\-","90 Years",{"count":499,"type":21},15630,"5 Years","In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.",[503,30,504,505,506,507,508,509],"Myocardial Infarction (MI)","Coronary Stenosis","Coronary Thrombosis","Coronary Artery Calcification","Coronary Occlusion","Coronary Syndrome","Coronary Artery Disease",[511],"PCI,DES, Radiation","2024-12-21",{"date":514,"type":52},"2024-12-27",{"date":516,"type":21},"2025-03-01",{"date":518,"type":21},"2025-12-31",{"name":520,"class":59},"Centre Cardiologique du Nord",{"id":522,"slug":523,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":17,"minAge":528,"maxAge":18,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":363},"100518641","integrative-molecular-analysis-of-individual-radiosensitivity-in-pediatric-oncology-100518641","NCT06033183","Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology","FOCUSO","Inclusion Criteria:\n\n* Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+\u002F- chemotherapy) for curative purposes.\n* Children or adolescents \\> 3 years old and \\\u003C 18 years old\n* Patient with an indication for radiotherapy as part of the primary tumor local control strategy\n* Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy \u002F fraction: 5 fr\u002Fweek) whatever the technique and the particle used\n* Patient affiliated with a social security scheme\n* Patient and\u002For parents or holders of parental authority having dated and signed an informed consent\n\nExclusion criteria:\n\n* Patients with contraindications to blood sampling\n* Patients with contraindications to radiotherapy\n* Palliative radiotherapy\n* Patient with previous RT treatment in the same area (re-irradiation)\n* Patient with an indication of hypofractionated RT\n* Patient follow-up not possible\n* Persons deprived of liberty or under guardianship (including curatorship)\n\nExclusion Criteria:\n\n\\-","3 Years",{"count":530,"type":21},100,[101],"Analysis of the individual radiosensitivity in pediatric oncology",[534,535,30],"Radiosensitivity","Pediatric Cancer","2024-11-19",{"date":538,"type":52},"2024-11-22",{"date":540,"type":52},"2023-12-02",{"date":542,"type":21},"2027-10-30",{"name":544,"class":130},"Neolys",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":89},"100565206","retrospective-perspective-observational-cohort-study-on-toxicity-and-efficacy-of-radiotherapy-in-pediatric-and-adult-patients-with-pediatric-histology-treated-at-the-pediatric-radiotherapy-of-the-cro-in-aviano-100565206","NCT06639165","Retrospective-perspective Observational Cohort Study on Toxicity and Efficacy of Radiotherapy in Pediatric and Adult Patients With Pediatric Histology Treated at the Pediatric Radiotherapy of the CRO in Aviano","RADIOPED","Inclusion Criteria:\n\n* Pediatric, adolescent, and young adult (\\\u003C25 years old) patients with malignant neoplasm\n* Adult patients (≥25 years) with malignant neoplasm with histology typical of pediatric age but rarely also found in adults and typically treated wherever possible in pediatric protocols (mainly: Central nervous system malignancies such as medulloblastomas and other embryonal tumors, ependymomas, and germ cell tumors; soft tissue and bone sarcomas such as rhabdomyosarcomas and Ewing's sarcomas; nephroblastomas; neuroblastomas)\n* Underwent radiation treatment at the Pediatric Radiotherapy Unit of the CRO in Aviano\n* Between October 24, 1991, and September 30, 2020, with regard to the retrospective phase of the study, and between October 1, 2020, and September 30, 2030, with regard to the prospective phase of the study\n* And who provide informed consent to the study if alive and traceable at the time of enrollment with regard to the retrospective phase of the study and necessarily with regard to the prospective phase. Regarding deceased or alive but untraceable patients enrollable in the retrospective phase of the study, since these are patients who had already given consent to data processing at the time of the radiation therapy being analyzed and registration\u002Fenrollment in any specific treatment\u002Fresearch protocols, no new consent is required for the study\n\nExclusion Criteria:\n\n\\- Anything not covered in the inclusion criteria",{"count":553,"type":21},280,"Radiotherapy key role in pediatric oncology, despite the potential side effects especially in the long term, including the risk of radioinduced second cancers.\n\nVery rarely malignant neoplasms typical of children and adolescents may present in adulthood, historically with a worse outcome, but for some of these histologies demonstrated recent results overlapping with those in pediatric age when treated with strategies similar to pediatric protocols and similar radiotherapy.\n\nLong-term data on outcome and incidence of potential toxicity late radiation therapy in these populations almost exclusively from epidemiologic studies or retrospective case series. Prospective data are lacking, particularly in patients treated with IMRT and specifically with certain IMRT modalities such as Helical Tomotherapy, for which the CRO pediatric radiotherapy has documented experience. The main objective is to evaluate the short- and long-term toxicity secondary to radiotherapy performed at the Pediatric Radiotherapy of the CRO in Aviano, with specific subgroup analyses aimed at highlighting any differences mainly by age, pathology and radiotherapy technique.",[30],"2024-10-10",{"date":558,"type":52},"2024-10-15",{"date":560,"type":52},"2020-10-01",{"date":562,"type":21},"2030-09-30",{"name":564,"class":59},"Centro di Riferimento Oncologico - Aviano",{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":430,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":89},"100532645","a-novel-target-delineation-scheme-in-high-grade-glioma-patients-a-randomized-single-blind-clinical-trial-100532645","NCT06215495","A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial","A Novel Target Delineation Scheme Based on RTOG(Radiation Therapy Oncology Group) and EORTC(European Organisation for Research and Treatment of Cancer) Guidelines Impact on Survival Time and Radiotherapy Complications in High-grade Glioma Patients: a Single-center Randomized Single-blind Clinical Trial","Inclusion Criteria:\n\n1. High-grade glioma (2021 WHO grade III or IV)\n2. Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70\n3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential\n4. The patient voluntarily joined this study and signed an informed consent form\n5. Willing to return for follow-up\n6. Willing to provide tissue and blood samples for this research\n7. Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)\n8. Radiotherapy within 4-6 weeks after surgery\n9. No contraindications for taking temozolomide\n\nExclusion Criteria:\n\n1. Low-grade glioma(2021 WHO grade I or II)\n2. had or having other type of malignant cancers\n3. not having been performed gross total resection of tumor\n4. Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness；\n5. Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;\n6. Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment)\n7. Unable to perform brain magnetic resonance imaging;\n8. Allergic to CT contrast agent, unable to perform enhanced CT examination;\n9. Remote transfer;\n10. Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma",{"count":573,"type":21},88,[101],"The main question it aims to answer are:\n\n1. whether the new target delineation scheme can improve Progression-free Survival\n2. whether it can reduce the incidence of radiation complications in high-grade glioma patients.\n\nParticipants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg \u002F ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 \\~ 200 mg \u002F ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.",[30,577,36,578,579],"MRI Simulated Positioning","Progression-free Survival","Overall Survival","2024-03-12",{"date":582,"type":52},"2024-03-15",{"date":584,"type":52},"2024-02-18",{"date":586,"type":21},"2027-06-01",{"name":588,"class":59},"Zhujiang Hospital",{"id":590,"slug":591,"hasResults":11,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":597,"targetDuration":141,"studyType":142,"phases":4,"briefSummary":598,"conditions":599,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":89},"100459117","cor-loco-regional-advanced-lung-cancer-treated-with-chemo-radiotherapy-cola-100459117","NCT05258448","COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)","The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR","COLA","Inclusion Criteria:\n\n* Age ≥ 18 Years\n* Inoperable and histologically\u002Fcytologically verified NSCLC.\n* Planned treatment with curative intent.\n* Capable of completing study procedures ECG and Cardiac MR.\n* Able of giving written and informed consent before study procedures are initiated.\n\nExclusion Criteria:\n\n* Vulnerable patients.\n* Patients with operable devices as pacemaker\u002FICD and cochlear implant or other conditions where MR scan is contraindicated.\n* Claustrophobia.",{"count":530,"type":21},"Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.",[600,601,602,30,603],"Cardiac Toxicity","Lung Cancer Stage III","Lung Cancer Stage II","Cardiac Disease","2023-12-05",{"date":606,"type":52},"2023-12-06",{"date":608,"type":52},"2015-08",{"date":610,"type":21},"2026-10",{"name":612,"class":59},"Odense University Hospital",{"id":614,"slug":615,"hasResults":11,"nctId":616,"briefTitle":617,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":267,"minAge":18,"maxAge":497,"enrollmentInfo":620,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":621,"conditions":622,"keywords":623,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":363},"100426358","post-prostatectomy-ablative-radiation-therapy-100426358","NCT04831970","POst-Prostatectomy Ablative Radiation Therapy","POPART","INCLUSION CRITERIA\n\n* Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy).\n* Pathologic T3N0\u002FNx disease or pathologic T2N0\u002FNx disease, with or without a positive prostatectomy surgical margin\n* Post-radical prostatectomy PSA of ≥ 0.1 - \\\u003C 2.0 ng\u002FmL.\n* Clinical local relapse assessed by Magnetic Resonance Imaging (MRI) of the pelvis\n* ECOG performance status of 0-1\n* No distant metastases at restaging (in case of biochemical failure), within 60 days prior to registration\n* Patients can be on androgen deprivation therapy\n* Ability to understand and willingness to sign a study-specific informed consent prior to study entry\n\nEXCLUSION CRITERIA\n\n* N1 and or M1 patients\n* Prior radiation of any kind to the prostate gland or pelvis\n* Prior brachytherapy is not allowed\n* History of inflammatory colitis or other active severe comorbidities\n* Patients who are on immunosuppressant medication",{"count":270,"type":21},"The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (\\\u003C 90 days from the end of treatment) and late (\\> 90 days) setting.",[30],[624,625,626,627,628],"SBRT","adjuvant RT","salvage RT","prostatectomy","prostatic bed","2022-10-24",{"date":631,"type":52},"2022-10-25",{"date":633,"type":52},"2021-04-15",{"date":635,"type":21},"2026-12-31",{"name":637,"class":59},"University of Milano Bicocca",{"id":639,"slug":640,"hasResults":11,"nctId":641,"briefTitle":642,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":644,"sex":17,"minAge":18,"maxAge":645,"enrollmentInfo":646,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":648,"conditions":649,"keywords":652,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":259},"100386031","cognitive-function-after-radiation-therapy-for-primary-brain-tumours-100386031","NCT04306432","Cognitive Function After Radiation Therapy for Primary Brain Tumours","Inclusion Criteria:\n\n* 18 years or older and Danish speaking.\n* Performance status WHO 0-2\n* Capable of cooperating on testing\n* Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas\n\nExclusion Criteria:\n\n* Glioblastoma\n* Performance status 3-4 (Karnofsky Performances of 60 or less)",true,"100 Years",{"count":647,"type":21},300,"This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.",[650,30,651],"Primary Brain Tumour","Cognitive Impairment",[653,654,655,656,657],"Brain tumour","Radiation therapy","Cognitive function","Hippocampus","Patient reported outcomes","2021-11-19",{"date":660,"type":52},"2021-12-02",{"date":662,"type":52},"2019-01-03",{"date":664,"type":21},"2034-03-31",{"name":218,"class":59},{"id":667,"slug":668,"hasResults":11,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":11,"sex":267,"minAge":429,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":363},"100356363","salvage-hypofractionated-accelerated-versus-standard-radiotherapy-for-biochemical-failure-after-prostatectomy-100356363","NCT03920033","Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy","Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study","SHARE","Inclusion Criteria:\n\n* Pathologically confirmed intermediate- or high-risk prostate cancer\n* Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng\u002FmL and \\\u003C=1.0 ng\u002FmL)\n* ECOG performance status 0-1\n* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3 Platelets ≥ 50,000 cells\u002Fmm3 Hemoglobin ≥ 8.0 g\u002Fdl\n* Appropriate values of kidney function within 6 months after enrollment Creatinine \\\u003C 2.0 ng\u002FdL\n* Appropriate values of liver function within 6 months after enrollment total bilirubin \\\u003C 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \\\u003C 2.5 X maximum normal value\n\nExclusion Criteria:\n\n* Clinically gross recurrent tumor\n* Presence of distant metastasis\n* Presence of pelvic LN metastasis\n* History of pelvic irradiation\n* History of cryotherapy or brachytherapy for prostate cancer\n* Double primary cancer other than skin\u002Fthyroid cancer\n* Combined serious morbidity",{"count":675,"type":21},288,[101],"Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.\n\nIt is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.",[147,679,680,681,682,683,30,105],"Biochemical Recurrence","Radiation","Hypofractionation","Dose Escalation","Survival","2021-01-15",{"date":686,"type":52},"2021-01-20",{"date":688,"type":52},"2019-05-01",{"date":690,"type":21},"2027-01-01",{"name":692,"class":59},"Asan Medical Center"]