[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypofractionation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypofractionation":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100499706","ultra-hypofractionnated-radiotherapy-with-hdr-brachytherapy-boost-100499706",false,"NCT05786742","Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.","ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.","HYPO-5","Inclusion Criteria:\n\n* Biopsy proven Prostate adenocarcinoma\n* Stage T1c, T2 (Annex 2)\n* Stage Nx or N0\n* Stage Mx or M0\n* PSA \\\u003C 20ng\u002Fml\n* Gleason Score 6 or 7\n* Having the ability to sing a written consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18ans\n* Clinical Stage T3 or T4\n* Stage N1\n* Stage M1\n* PSA \\> 20\n* Gleason Score 8 to 10\n* IPSS Score \\> 20 alpha-blocking medication.\n* Prior pelvic radiotherapy.\n* History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)\n* Past history of Inflammatory Bowell Disease\n* Bilateral hip prosthesis",true,"MALE","18 Years","95 Years",{"count":22,"type":23},205,"ESTIMATED","INTERVENTIONAL",[26],"NA","Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \\& 10 years.",[29,30,31,32,33,34],"Prostate Cancer","Radiotherapy Side Effect","Hypofractionation","Brachytherapy","Radiotherapy","Localized Prostate Carcinoma",[36,37,38],"hypo fractionation","brachytherapy","Ultra Hypo fractionation","RECRUITING","2025-09-07",{"date":42,"type":43},"2025-09-09","ACTUAL",{"date":45,"type":43},"2014-04",{"date":47,"type":23},"2033-12",{"name":49,"class":50},"CHU de Quebec-Universite Laval","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":51},"100398799","hypofractionated-adjuvant-radiotherapy-in-1-versus-2-weeks-in-high-risk-patients-with-breast-cancer-hypart-100398799","NCT04472845","HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART).","HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART): A Non-inferiority, Open-label, Phase III Randomized Trial.","HYPART","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Female or male\n3. Invasive carcinoma of the breast\n4. Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed)\n5. Concurrent trastuzumab and hormone therapy is allowed\n6. Axillary staging and\u002For dissection\n7. Complete microscopic excision of primary tumour\n8. pT3-4pN2-3 M0 disease\n9. Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy.\n10. Written informed consent\n11. Able to comply with follow-up\n\nExclusion Criteria:\n\n1. Supraclavicular node or internal mammary node or distant metastasis\n2. Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or(ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free\n3. Contralateral breast cancer, including DCIS, irrespective of date of diagnosis\n4. Breast reconstruction using implants\n5. Pregnancy\n6. Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy allowed)","FEMALE",{"count":62,"type":23},1018,[26],"We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy\u002F15#\u002F3wks to the chest wall after mastectomy and 40Gy\u002F16#\u002F3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation helps radiation centers worldwide to meet the growing need for radiation treatment in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.",[66,31,30],"Breast Cancer","2022-12-07",{"date":69,"type":43},"2022-12-08",{"date":71,"type":43},"2021-03-30",{"date":73,"type":23},"2028-08-20",{"name":75,"class":50},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"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","20 Years",{"count":86,"type":23},288,[26],"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.",[29,90,91,31,92,93,94,95],"Biochemical Recurrence","Radiation","Dose Escalation","Survival","Radiation Toxicity","Quality of Life","2021-01-15",{"date":98,"type":43},"2021-01-20",{"date":100,"type":43},"2019-05-01",{"date":102,"type":23},"2027-01-01",{"name":104,"class":50},"Asan Medical Center",2]