MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Allegheny Health Network
NOT_YET_RECRUITING
Pittsburgh
Wisconsin
Medical College of Wisconsin Cancer Center
NOT_YET_RECRUITING
Milwaukee
Other Locations
Australia
Austin Health
NOT_YET_RECRUITING
Heidelberg
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Ali Hosni
ali.hosni@uhn.ca
416-946-2360
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 80
Related Therapeutic Areas
Sponsors
Collaborators: Medical College of Wisconsin
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov