CancerPhase 2ART-HypoNCT07516210
Adaptive Radiotherapy for Safe Hypofractionation
A Phase 2 study testing Adaptive Hypofractionated Radiotherapy and Standard-of-care Radiotherapy in people with Cancer and Endometrial Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Endometrial Cancer, Prostate Cancer
- What is being tested?
- Adaptive Hypofractionated Radiotherapy and Standard-of-care Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteCanada
- Study dates
- May 2026to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 0H5
colbelliveau@hotmail.com
About this study
Official title: Adaptive Radiotherapy for Safe Hypofractionation (ART-Hypo): A Bayesian Registry-Based Randomized Controlled 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.
Read more
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.
- Conditions
- Cancer, Endometrial Cancer, Prostate Cancer, Cervical Cancer, Rectal Cancers
- Being tested
- Adaptive Hypofractionated Radiotherapy, Standard-of-care Radiotherapy
- Medical subject headings
- Neoplasms, Endometrial Neoplasms, Prostatic Neoplasms, Uterine Cervical Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Hypofractionated RadiotherapyRadiation
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 RadiotherapyRadiation
Planned radiotherapy delivered according to physician discretion, without daily online contour adaptation or plan re-optimization prior to treatment delivery.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care Radiotherapy | Active comparator | Not described Receives: Radiation: Standard-of-care Radiotherapy |
| Adaptive Hypofractionated Radiotherapy (ART-Hypo) | Experimental | Not described Receives: Radiation: Adaptive Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (7)
Acute adverse effects
Measured: 3 months
EORTC QLQ-C30 Global Health Status / Quality of Life Score
For all patients
Measured: 12 and 24 months
EPIC-26 Domain Scores
Specifically for prostate cancer strata
Measured: 12 and 24 months
Progression free survival
Measured: 24 months
Time to distant metastases
Measured: 24 months
Treatment efficiency
Measured as the total time on the treatment table per fraction and the cumulative treatment time across all fractions.
Measured: Up to four weeks
Dosimetric Assessment
Measured: Up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maroie Barkati, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516210
- Sponsor's protocol ID
- 2026-13479
- Acronym
- ART-Hypo
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Radiotherapy for Safe Hypofractionation (ART-Hypo): A Bayesian Registry-Based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07516210
- Acronym / sponsor ID
- ART-Hypo / 2026-13479
- Conditions
- Cancer, Endometrial Cancer, Prostate Cancer, Cervical Cancer, Rectal Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care Radiotherapy | Active comparator | Radiation: Standard-of-care Radiotherapy |
| Adaptive Hypofractionated Radiotherapy (ART-Hypo) | Experimental | Radiation: Adaptive Hypofractionated Radiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Hypofractionated RadiotherapyAdaptive 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 | Adaptive Hypofractionated Radiotherapy (ART-Hypo) |
| Standard-of-care RadiotherapyPlanned radiotherapy delivered according to physician discretion, without daily online contour adaptation or plan re-optimization prior to treatment delivery. | Radiation | Standard-of-care Radiotherapy |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maroie Barkati, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adaptive Hypofractionated Radiotherapy and Standard-of-care Radiotherapy in people with Cancer and Endometrial Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mom Phat (514-890-8000 ext. 11171, mom.phat.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-reported Grade 2+ toxicity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.