REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation

Inclusion Criteria

• Age ≥18 years.
• Patients must have stage T1-4N+M0 or T3/T4N0M0 locally advanced anal cancer as evidenced by a PET scan AND either a CT with contrast of the abdomen/pelvis or an MRI with contrast of the pelvis. All imaging must be from within 60 days prior to registration.
• Note: Patients with T2N0 disease will be allowed if the primary tumor is >4 cm. Patients with Stage I-T1N0M0 or Stage II-T2N0M0 (tumor ≤ 4cm) will be ineligible for participation.
• Patients with perianal cancer that is HPV associated (P16+) will be eligible if the tumor extends to the anal verge and the CTV will include the mesorectal, internal/external iliac, and inguinal lymph nodes.
• Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible.
• ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A).
• Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator.
• Creatinine Clearance must be > 30 ml/min.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Any prior pelvic radiation.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
• Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine. a. Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Pregnant or breastfeeding women are excluded from this study.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.
• Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.