MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
NCT06050707 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-03-06
Summary
The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.
Conditions
- Anal Squamous Cell Carcinoma
Interventions
- RADIATION
-
Radiotherapy - Low risk group
20 fractions completed in 4 weeks
- RADIATION
-
Radiotherapy - Standard risk group
25 fractions completed in 5 weeks
- RADIATION
-
Radiotherapy - Intermediate risk group
30 fractions completed in 6 weeks
- RADIATION
-
Radiotherapy - High risk group
35 fractions completed in 7 weeks
Sponsors & Collaborators
-
Medical College of Wisconsin
collaborator OTHER -
University Health Network, Toronto
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-29
- Primary Completion
- 2028-09-01
- Completion
- 2028-09-01
Countries
- United States
- Australia
- Canada
Study Locations
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