Adaptive Radiotherapy for Cancer

(ART-Hypo Trial)

Overseen By Eva Eva Nkurunziza

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pacemaker, Metal implant, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Maroie Barkati, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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: Contraindications to MRI (e.g., pacemaker, potentially mobile metal implant, claustrophobia).

For intact prostate stratum: Hip replacement, or other pelvic metalwork which causes significant artefact on MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard-of-care radiotherapy or hypofractionated adaptive radiotherapy

Up to 4 weeks

Daily visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits as per protocol

Long-term follow-up

Monitoring of oncologic outcomes and patient-reported outcomes

12 to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Hypofractionated Radiotherapy
• Standard-of-care Radiotherapy

How Is the Trial Designed?

Group I: Adaptive Hypofractionated Radiotherapy (ART-Hypo) Experimental Treatment 1 Intervention

Group II: Standard-of-care Radiotherapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+