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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
20 fractions completed in 4 weeks
25 fractions completed in 5 weeks
30 fractions completed in 6 weeks
35 fractions completed in 7 weeks
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGMedical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGAustin Health
Heidelberg, Victoria, Australia
NOT_YET_RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGCHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
NOT_YET_RECRUITINGChange 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
Presence of distant metastasis (DM)
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
Time frame: 5 years
Colostomy rate
The presence of a colostomy until colostomy removal.
Time frame: 5 years
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.
Time frame: 5 years
Overall survival (OS)
The time from the date of registration to the date of death for any cause.
Time frame: 5 years
Physician-reported toxicities
Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.
Time frame: 5 years
Patient Reported Outcomes
Using the Common Terminology Criteria of Adverse Events
Time frame: 5 years
Quality of life (QOL)
Based on the completion of the European Organisation For Research And Treatment Of Cancer (EORTC-C30) questionnaire. The EORTC-C30 questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.
Time frame: 5 years
Quality of life (QOL)
Based on the completion of the European Organisation For Research And Treatment Of Cancer (EORTC-AN27) questionnaire. EORTC QLQ-ANL27 includes four quality of life domains: pain, bowel, sexual and stoma care problems and five single item (frequent urination, keeping clean, proximity to toilet, lower limb oedema, planning activities)
Time frame: 5 years
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