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NCT Number: NCT07516210

Adaptive Radiotherapy for Safe Hypofractionation

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.

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Key information

Conditions

Cancer Cervical Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Cancers Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 0H5, Canada

Location contact

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive Hypofractionated Radiotherapy

Radiation

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.

Standard-of-care Radiotherapy

Radiation

Planned radiotherapy delivered according to physician discretion, without daily online contour adaptation or plan re-optimization prior to treatment delivery.

Primary outcomes

  1. Physician-reported Grade 2+ toxicity

    Time frame: 24 months

    The primary endpoint is the cumulative incidence of physician-reported Grade 2+ toxicity (CTCAE v5) occurring within 24 months from the completion of radiotherapy.

Secondary outcomes

  1. Acute adverse effects

    Time frame: 3 months

  2. EORTC QLQ-C30 Global Health Status / Quality of Life Score

    Time frame: 12 and 24 months

    For all patients

  3. EPIC-26 Domain Scores

    Time frame: 12 and 24 months

    Specifically for prostate cancer strata

  4. Progression free survival

    Time frame: 24 months

  5. Time to distant metastases

    Time frame: 24 months

  6. Treatment efficiency

    Time frame: Up to four weeks

    Measured as the total time on the treatment table per fraction and the cumulative treatment time across all fractions.

  7. Dosimetric Assessment

    Time frame: Up to four weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Eva Nkurunziza

CONTACT

[email protected]

514-890-8000 ext. 30898

Mom Phat

CONTACT

[email protected]

514-890-8000 ext. 11171

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Adaptive Radiotherapy for Safe Hypofractionation (ART-Hypo): A Bayesian Registry-Based Randomized Controlled Trial

Acronym: ART-Hypo

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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