MR-guided radiation therapy for anal cancer with tailored treatment
Official title: MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Run by University Health Network, Toronto · NCT06050707 · Data updated 2026-11-12
This study is testing a personalized radiation therapy approach for patients with anal cancer to see if adjusting treatment based on their individual risk levels and biomarkers can improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Pittsburgh, Pennsylvania and 4 other locations) |
| Status | Recruiting |
| Started | September 29, 2023 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT06050707 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with pathologically confirmed anal squamous cell carcinoma who are eligible for definitive radiation or chemoradiation therapy.
✕Probably not a fit
Patients with a history of previous chemotherapy, radiation therapy, or curative surgical treatment for anal cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II, single-arm, open-label trial investigates the use of MR-guided radiation therapy for patients with anal squamous cell carcinoma, employing a risk-adaptive approach to determine radiation doses and chemotherapy cycles based on clinical and biological biomarkers. Patients will be categorized into four risk groups: low, standard, intermediate, and high risk, and will receive tailored treatment accordingly. The study will analyze HPV DNA to identify biomarkers that predict responses to chemoradiotherapy and associated toxicities. Participants will be monitored for up to five years post-treatment, with opportunities for blood and tissue sampling.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with anal cancer.
How similar studies have gone: Other studies utilizing risk-adaptive treatment approaches have shown promise, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible. * Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed) * Patients must be eligible for definitive RT or CRT * Must be ≥ 18 years of age * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: * Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer. * Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study. * Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Where it's running
-
Princess Margaret Cancer Centre
Toronto, Ontario, Canada Recruiting -
Allegheny Health Network
Pittsburgh, Pennsylvania, United States Not yet recruiting -
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States Not yet recruiting -
Austin Health
Heidelberg, Victoria, Australia Not yet recruiting -
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada Not yet recruiting
Study contacts
- Study coordinator: Ali Hosni
- Email: ali.hosni@uhn.ca
- Phone: 416-946-2360
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Retifanlimab after chemoradiation for anal cancer
This study tests whether retifanlimab can help people with anal squamous cell carcinoma who have completed chemoradiation and still have residual disease.
-
EVOLVE104 for advanced bladder and other squamous cell cancers
This will try EVOLVE104, an experimental drug, in adults with advanced or metastatic bladder or other squamous cell cancers who have already tried or cannot take standard treatments.
-
High resolution anal examination for HPV and anal cancer detection
This study is testing how well high-resolution anal exams can help find high-risk HPV and anal cancer in people who are more likely to have these issues.
-
Adaptive radiation therapy for anal cancer
This study is testing a new way of giving radiation therapy that changes daily based on how the tumor responds, to see if it helps people with advanced anal cancer while protecting healthy tissue.
-
Daily online adaptive radiotherapy for anal cancer
This study is testing if daily online adaptive radiotherapy can help people with anal cancer experience less stomach problems compared to standard radiation treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.