Study on MR-Guided Radiation Therapy for Anal Cancer with a Risk-Optimized Treatment Approach

Sponsor: University Health Network, Toronto

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06050707

Provider View

This clinical trial is testing a new way to use MR-guided radiation therapy for treating anal cancer. The study aims to tailor treatment based on the patient's risk level and to explore how HPV DNA might predict treatment response and side effects.

Patient Parameters

Program Overview

This study is exploring a new method of delivering radiation therapy for anal cancer using MR-guided technology. The treatment is customized based on the patient's risk level, categorized into four groups: low, standard, intermediate, and high risk. Researchers will also analyze HPV DNA to find new markers that could predict how well patients respond to treatment and what side effects they might experience.

Description

Participants in this study will receive a personalized dose of radiation and chemotherapy cycles based on specific clinical and biological markers for anal squamous cell carcinoma. The radiation therapy will be administered using advanced MR-guided technology to ensure precision. Patients will be monitored for up to five years after treatment and will need to complete questionnaires and attend clinic visits. They may also choose to provide blood and tissue samples during the study to help researchers gather more information.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with anal squamous cell carcinoma, including certain non-keratinizing types like basaloid or cloacogenic.
  • Cancer stage between T1-4 N0-1 M0 according to international cancer staging guidelines.
  • Eligible for radiation therapy or combined chemo-radiation therapy.
  • Aged 18 years or older.
  • In good general health with an ECOG performance status of 0 to 2.

Exclusion Criteria

  • Have had previous chemotherapy, radiation, or surgery aimed at curing anal cancer.
  • Have had prior radiation to the abdomen or pelvis that would overlap with the current study's treatment area.
  • Have a history of another cancer unless they have been disease-free for at least two years and are considered at low risk for recurrence. Exceptions include cervical cancer in situ and certain skin cancers if treated within the last five years.

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