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

Anal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06050707
Study type Interventional
Source University Health Network, Toronto
Contact Ali Hosni
Phone 416-946-2360
Email ali.hosni@uhn.ca
Status Recruiting
Phase Phase 2
Start date September 29, 2023
Completion date September 1, 2028
View Details
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