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

Eligibility Criteria

• 1. Age ≥18 years.
• 2. 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.
• 1. 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.
• 2. 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.
• 3. Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible.
• 3. ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A).
• 4. Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator.
• 5. Creatinine Clearance must be \> 30 ml/min.
• 6. Ability to understand and the willingness to sign a written informed consent document.
• 1. Any prior pelvic radiation.
• 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
• 3. Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine.
• 4. Pregnant or breastfeeding women are excluded from this study.
• 5. 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.
• 6. Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.