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

Recruiting now · Phase 2

Conditions studied: Anal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06050707

Run by

University Health Network, Toronto

People needed

80

Starts

2023-09-29

Expected to finish

2028-09-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States
• Austin Health — Heidelberg, Victoria, Australia
• CHUM - Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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