High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management

Inclusion Criteria

• Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus
• Prior pelvic external beam radiotherapy (EBRT)
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• At least 4 weeks from prior major surgery or radiotherapy
• Have undergone surgical, medical and radiation oncology evaluations to confirm: * Eligible for infusional fluorouracil (5-FU) or capecitabine * Will not undergo surgery for the study disease * Able to receive HDR brachytherapy
• Absolute neutrophil count (ANC) >= 1.5 cells/mm^3
• Platelets (PLT) >= 100,000/mm^3
• Creatinine < 1.5 x the upper limit of normal (ULN) or calculated creatinine clearance >= 50 cc/min
• Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN or < 5 x ULN if known liver metastases
• Normal cardiac function: * No active coronary artery disease * No New York Heart Association class II, III, or IV disease * No arrhythmia requiring treatment
• Maximum tumor length of 7 cm at time of brachytherapy treatment start

Exclusion Criteria

• Women who are pregnant
• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period and after receipt of brachytherapy; male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy
• Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study
• Patients on concurrent anti-cancer therapy other than that allowed in the study
• Contraindications to general anesthesia