[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632632":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":43,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":11,"maxAge":11,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard-of-care Radiotherapy","ACTIVE_COMPARATOR",null,[13],"Radiation: Standard-of-care Radiotherapy",{"label":15,"type":16,"description":11,"interventionNames":17},"Adaptive Hypofractionated Radiotherapy (ART-Hypo)","EXPERIMENTAL",[18],"Radiation: Adaptive Hypofractionated Radiotherapy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"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.",[15],{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"Planned radiotherapy delivered according to physician discretion, without daily online contour adaptation or plan re-optimization prior to treatment delivery.",[9],[29],{"name":30,"affiliation":5,"role":31},"Maroie Barkati, MD","PRINCIPAL_INVESTIGATOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Mom Phat","CONTACT","514-890-8000","11171","mom.phat.chum@ssss.gouv.qc.ca",{"name":40,"role":35,"phone":36,"phoneExt":41,"email":42},"Eva Eva Nkurunziza","30898","eva-sabrina.nkurunziza.chum@ssss.gouv.qc.ca",[44],{"facility":45,"status":11,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Centre Hospitalier de l'Université de Montréal","Montreal","Quebec","H2L 0H5","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58],{"name":11,"role":35,"phone":11,"phoneExt":11,"email":59},"colbelliveau@hotmail.com",{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632632","phase-2-adaptive-radiotherapy-for-safe-hypofractionation-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":72,"type":73},264,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79,80,81,82,83],"Cancer","Endometrial Cancer","Prostate Cancer","Cervical Cancer","Rectal Cancers","NOT_YET_RECRUITING","2026-04-02",{"date":87,"type":88},"2026-04-07","ACTUAL",{"date":90,"type":73},"2026-05",{"date":92,"type":73},"2030-05",{"name":5,"class":6},1]