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

RecruitingPhase 2Ages 18 Years - anyAllUniversity Health Network, Toronto
NCT06050707 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Radiotherapy - Low risk group
  • Radiotherapy - Standard risk group
  • Radiotherapy - Intermediate risk group
  • Radiotherapy - High risk group
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Where

5 sites
Allegheny Health Network
Pittsburgh, United States
Medical College of Wisconsin Cancer Center
Milwaukee, United States
Austin Health
Heidelberg, Australia
Princess Margaret Cancer Centre
Toronto, Canada
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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