Status:
RECRUITING
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Medical College of Wisconsin
Conditions:
Anal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a risk-stratified dose of treatment (radiation dose and chemotherapy number of cycle...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06050707
Start Date
September 29 2023
End Date
September 1 2028
Last Update
June 13 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
2
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
3
Austin Health
Heidelberg, Victoria, Australia, 3084
4
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1