RecruitingPhase 2NCT06050707

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


Sponsor

University Health Network, Toronto

Enrollment

80 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses an advanced, adaptive form of radiation therapy (guided by MRI scans) for anal cancer, adjusting the radiation plan in real time to the patient's anatomy. The goal is to deliver precise treatment with fewer side effects. **You may be eligible if...** - You have been diagnosed with anal squamous cell carcinoma confirmed by biopsy - Your cancer has not spread to distant organs (stages T1–T4, N0–N1) - You are eligible for definitive (curative) radiation therapy, with or without chemotherapy - You are 18 or older and in acceptable overall health **You may NOT be eligible if...** - You have had prior chemotherapy, radiation, or surgery for anal cancer - You have had prior radiation to the pelvic/abdominal area that would overlap with current treatment - You have active inflammatory bowel disease (Crohn's or ulcerative colitis) or connective tissue disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy - Low risk group

20 fractions completed in 4 weeks

RADIATIONRadiotherapy - Standard risk group

25 fractions completed in 5 weeks

RADIATIONRadiotherapy - Intermediate risk group

30 fractions completed in 6 weeks

RADIATIONRadiotherapy - High risk group

35 fractions completed in 7 weeks


Locations(4)

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Austin Health

Heidelberg, Victoria, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06050707


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