NCT06050707

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 cycles) based on predefined clinical and biological biomarkers for anal squamous cell carcinoma (SCC). Radiotherapy will be delivered on the MR-Linac for image-guided-radiation therapy (IGRT). Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits. Patients have the option to complete blood and tissue samples during the study.

Conditions

• Anal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-29
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2023-09-22
• Last updated: 2026-03-06

Locations

4 sites across 3 countries: United States, Australia, Canada