[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632632":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":16,"studyPopulation":16,"armGroups":41,"interventions":52,"overallOfficials":61,"centralContacts":65,"locations":76,"responsibleParty":93,"collaborators":16,"id":95,"slug":16,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":16,"maxAge":16,"enrollmentInfo":103,"targetDuration":16,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":16,"overallStatus":116,"whyStopped":16,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Physician-reported Grade 2+ toxicity","The primary endpoint is the cumulative incidence of physician-reported Grade 2+ toxicity (CTCAE v5) occurring within 24 months from the completion of radiotherapy.","24 months",[14,18,22,25,27,29,33],{"measure":15,"description":16,"timeFrame":17},"Acute adverse effects",null,"3 months",{"measure":19,"description":20,"timeFrame":21},"EORTC QLQ-C30 Global Health Status \u002F Quality of Life Score","For all patients","12 and 24 months",{"measure":23,"description":24,"timeFrame":21},"EPIC-26 Domain Scores","Specifically for prostate cancer strata",{"measure":26,"description":16,"timeFrame":12},"Progression free survival",{"measure":28,"description":16,"timeFrame":12},"Time to distant metastases",{"measure":30,"description":31,"timeFrame":32},"Treatment efficiency","Measured as the total time on the treatment table per fraction and the cumulative treatment time across all fractions.","Up to four weeks",{"measure":34,"description":16,"timeFrame":32},"Dosimetric Assessment",{"allocation":36,"interventionModel":37,"interventionModelDescription":16,"primaryPurpose":38,"observationalModel":16,"timePerspective":16,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":16,"whoMasked":16},"NONE",[42,47],{"label":43,"type":44,"description":16,"interventionNames":45},"Standard-of-care Radiotherapy","ACTIVE_COMPARATOR",[46],"Radiation: Standard-of-care Radiotherapy",{"label":48,"type":49,"description":16,"interventionNames":50},"Adaptive Hypofractionated Radiotherapy (ART-Hypo)","EXPERIMENTAL",[51],"Radiation: Adaptive Hypofractionated Radiotherapy",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":16},"RADIATION","Adaptive Hypofractionated Radiotherapy","Adaptive Radiotherapy (ART) in this study is a real-time, online daily adaptation approach in which high-resolution on-table imaging (kV-CBCT or real-time MRI) is performed prior to each fraction, with the treatment plan immediately recalculated or re-optimized using reduced PTV margins before delivery if needed, enabling safe hypofractionation through tighter margins.",[48],{"type":54,"name":43,"description":59,"armGroupLabels":60,"otherNames":16},"Planned radiotherapy delivered according to physician discretion, without daily online contour adaptation or plan re-optimization prior to treatment delivery.",[43],[62],{"name":63,"affiliation":5,"role":64},"Maroie Barkati, MD","PRINCIPAL_INVESTIGATOR",[66,72],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Mom Phat","CONTACT","514-890-8000","11171","mom.phat.chum@ssss.gouv.qc.ca",{"name":73,"role":68,"phone":69,"phoneExt":74,"email":75},"Eva Eva Nkurunziza","30898","eva-sabrina.nkurunziza.chum@ssss.gouv.qc.ca",[77],{"facility":78,"status":16,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Centre Hospitalier de l'Université de Montréal","Montreal","Quebec","H2L 0H5","Canada","CA",{"type":85,"coordinates":86},"Point",[87,88],-73.58781,45.50884,{"lat":88,"lon":87},[91],{"name":16,"role":68,"phone":16,"phoneExt":16,"email":92},"colbelliveau@hotmail.com",{"type":94,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100632632",false,"NCT07516210","Adaptive Radiotherapy for Safe Hypofractionation","Adaptive Radiotherapy for Safe Hypofractionation (ART-Hypo): A Bayesian Registry-Based Randomized Controlled Trial","ART-Hypo","Inclusion Criteria:\n\n\\- Enrolled in PERa registry (CHUM CER 17.0.32), consented to contact for investigational trials, consented to serve as control, and randomly selected to be offered the experimental intervention.\n\nExclusion Criteria:\n\n\\- For intact prostate stratum : 1. Contraindications to MRI (e.g., pacemaker, potentially mobile metal implant, claustrophobia). 2. Hip replacement, or other pelvic metalwork which causes significant artefact on MRI.","ALL",{"count":104,"type":105},264,"ESTIMATED","INTERVENTIONAL",[108],"PHASE2","This phase II, registry-based cohort-multiple randomized controlled trial (cmRCT) evaluates whether daily online adaptive radiotherapy (ART) enables the safe delivery of hypofractionated, iso-biologically equivalent (EQD2) external beam radiotherapy compared with standard-of-care (SOC) fractionation.\n\nConventional radiotherapy requires generous planning target volume (PTV) margins to account for inter-fraction anatomical variation, which increases radiation exposure to surrounding organs at risk (OARs) and may contribute to toxicity. Modern ART platforms using daily on-table imaging (kV-CBCT or MRI guidance) allow real-time contour adaptation and online plan re-optimization based on same-day anatomy. This approach enables margin reduction while maintaining target coverage and may permit safe hypofractionation.\n\nEligible patients enrolled in an institutional prospective registry will be randomized (1:1) to receive either SOC radiotherapy or hypofractionated ART across multiple pelvic disease strata (post-prostatectomy prostate cancer, intact prostate cancer, endometrial cancer, cervical cancer, and rectal cancer).\n\nThe primary objective is to demonstrate non-inferiority of hypofractionated ART compared with SOC in terms of cumulative incidence of Grade ≥2 toxicity (CTCAE v5). Secondary outcomes include acute and late toxicity, oncologic outcomes (progression-free survival, locoregional failure, distant metastases, overall survival), patient-reported outcomes, treatment efficiency, and dosimetric parameters.\n\nA Bayesian monitoring framework with pre-specified safety and futility stopping rules will be used to ensure patient safety and clinical equipoise throughout the trial.",[111,112,113,114,115],"Cancer","Endometrial Cancer","Prostate Cancer","Cervical Cancer","Rectal Cancers","NOT_YET_RECRUITING","2026-04-02",{"date":119,"type":120},"2026-04-07","ACTUAL",{"date":122,"type":105},"2026-05",{"date":124,"type":105},"2030-05",{"name":5,"class":6},1]