Actively Recruiting
MR-Adaptive Radiation Therapy for Anal Cancer With Escalated Treatment in a Risk-Optimized Approach
Led by University Health Network, Toronto · Updated on 2026-03-06
80
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
M
Medical College of Wisconsin
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates MR-guided radiation therapy (RT) with risk-adapted dose selection for patients diagnosed with anal squamous cell carcinoma (SCC). The study aims to tailor treatment intensity based on clinical and biological markers, including human papillomavirus (HPV) DNA analysis to identify new indicators predicting response and side effects to chemoradiotherapy (CRT). It is a phase II, open-label trial exploring four risk groups: low, standard, intermediate, and high risk. Participants will receive radiation therapy delivered using an MR-Linac for precise image-guided RT. Treatment doses vary by risk group, ranging from 20 fractions over 4 weeks for low risk to 35 fractions over 7 weeks for high risk. Chemotherapy cycles are also adjusted according to risk. After treatment, patients have the option to provide blood and tissue samples to support biomarker research. During the study, patients will be monitored through regular clinic visits and questionnaires for up to five years post-radiotherapy. Researchers will assess outcomes including locoregional failure at 2 years, distant metastasis, colostomy rates, disease-free and overall survival, physician-reported toxicities, patient-reported outcomes, and quality of life over 5 years. This comprehensive follow-up aims to evaluate treatment impact and long-term safety.
CONDITIONS
Brief Title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of anal squamous cell carcinoma, including non-keratinizing types
- Clinical stage T1-4 N0-1 M0 according to UICC/AJCC 8th edition
- Eligible for definitive radiation therapy or chemoradiotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
You will not qualify if you...
- Previous chemotherapy, radiation therapy, or curative surgery for anal cancer
- Prior radiation to the abdomino-pelvic area overlapping with planned treatment
- History of other malignancies unless disease-free for at least 2 years and low risk of recurrence
- Recent diagnosis (within 5 years) of cervical cancer in situ or skin basal/squamous cell carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 7 weeks depending on risk group
Participants receive a risk-stratified dose of radiotherapy based on clinical and biological biomarkers. Treatment duration varies by risk group.
Daily visits for radiotherapy sessions during treatment weeks
Duration - Up to 5 years
Participants are followed for up to 5 years after radiotherapy with clinic visits and questionnaires to monitor outcomes and quality of life. Optional blood and tissue samples may be collected.
Periodic clinic visits and questionnaires over 5 years
Trial Site Locations
Total: 4 locations
1
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
2
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
3
Austin Health
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
4
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
Research Team
A
Ali Hosni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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