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.
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
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.
Single group
Radiotherapy - Low risk group
Radiation20 fractions completed in 4 weeks
Radiotherapy - Standard risk group
Radiation25 fractions completed in 5 weeks
Radiotherapy - Intermediate risk group
Radiation30 fractions completed in 6 weeks
Radiotherapy - High risk group
Radiation35 fractions completed in 7 weeks
Change in locoregional failure (LRF) at Year 2
Any local or regional failure from the date of registration to the date of any of the local or regional failure.
Presence of distant metastasis (DM)
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
Colostomy rate
The presence of a colostomy until colostomy removal.
Disease free survival (DFS)
The time from the date of registration to the date of first record of any of the following events including local, regional, distant failure, or death due to any cause.
Overall survival (OS)
The time from the date of registration to the date of death for any cause.
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University Health Network, Toronto
Lead sponsor
Medical College of Wisconsin
Collaborator
