Study on Reducing Radiation Dose to Lymph Nodes for Lowering Side Effects in Anal Cancer Treatment

Sponsor: University of Cincinnati

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05902533

Provider View

This clinical trial is exploring whether using a lower dose of radiation to the lymph nodes can reduce side effects for anal cancer patients undergoing chemoradiation, compared to the standard radiation dose.

Patient Parameters

Program Overview

The aim of this study is to find out if giving a lower dose of radiation to the lymph nodes can help reduce side effects in patients with anal cancer who are receiving chemoradiation. The study will compare the side effects experienced by patients receiving the reduced dose to those who received the standard dose in previous studies.

Description

This study involves multiple centers and focuses on whether a lower dose of radiation to the lymph nodes (30.6 Gy) can reduce side effects in anal cancer patients. The side effects will be measured using a specific toxicity index and patient-reported outcomes for gastrointestinal issues, like diarrhea. The results will be compared to those from past patients who received the standard radiation dose.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have locally advanced anal cancer, specifically stage T1-4N+M0 or T3/T4N0M0, confirmed by a PET scan and either a CT or MRI with contrast.
    • Patients with T2N0 disease can join if the primary tumor is larger than 4 cm.
    • Patients with HPV-associated perianal cancer extending to the anal verge are eligible if certain lymph nodes are included in the treatment area.
    • Patients who had the primary tumor removed but still have node-positive or residual disease are eligible.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • Must be able to receive treatment with capecitabine and Mitomycin C.
  • Must have a creatinine clearance greater than 30 ml/min.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Have had previous radiation to the pelvic area.
  • Have a history of allergic reactions to similar drugs as capecitabine.
  • Have uncontrolled health issues that would prevent receiving radiation or capecitabine.
    • Note: HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Pregnant or breastfeeding women cannot participate.
  • Have another cancer that could interfere with the study treatment.
  • Have active autoimmune or connective tissue diseases requiring systemic treatment.

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