Adaptive Radiotherapy for Safe Hypofractionation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adaptive Hypofractionated Radiotherapy, Standard-of-care Radiotherapy.
- Who it may be relevant to
- Registry conditions: Cancer, Endometrial Cancer, Prostate Cancer, Cervical Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptive Radiotherapy for Safe Hypofractionation (ART-Hypo): A Bayesian Registry-Based Randomized Controlled Trial
Overview
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. Conventional 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. Eligible 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). The 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. A Bayesian monitoring framework with pre-specified safety and futility stopping rules will be used to ensure patient safety and clinical equipoise throughout the trial.
Interventions
- 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. - Radiation Standard-of-care Radiotherapy
Planned radiotherapy delivered according to physician discretion, without daily online contour adaptation or plan re-optimization prior to treatment delivery.
Primary outcome measures
- Physician-reported Grade 2+ toxicity [Time frame: 24 months]
Secondary outcome measures (7)
- Acute adverse effects [Time frame: 3 months]
- EORTC QLQ-C30 Global Health Status / Quality of Life Score [Time frame: 12 and 24 months]
- EPIC-26 Domain Scores [Time frame: 12 and 24 months]
- Progression free survival [Time frame: 24 months]
- Time to distant metastases [Time frame: 24 months]
- Treatment efficiency [Time frame: Up to four weeks]
- Dosimetric Assessment [Time frame: Up to four weeks]
Eligibility criteria
Inclusion criteria
\- 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.
Exclusion criteria
\- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centre Hospitalier de l'Université de Montréal — Montreal
Identifiers
NCT: NCT07516210 · 2026-13479