RecruitingInterventionalPhase 2

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

NCT ID: NCT06050707Sponsor: University Health Network, TorontoLast updated: 2026-06-10

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.

Detailed 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.

Arms & 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

Outcome measures

Primary

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.
Time frame: 2 years

Secondary

Presence of distant metastasis (DM)
Time frame: 5 years
Colostomy rate
Time frame: 5 years
Disease free survival (DFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Physician-reported toxicities
Time frame: 5 years
Patient Reported Outcomes
Time frame: 5 years
Quality of life (QOL)
Time frame: 5 years
Quality of life (QOL)
Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (2)

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212

Not Yet Recruiting

Alexander Kirichenko, MD · Contact

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226

Not Yet Recruiting

William A Hall, MD · Contact