Dose Escalation Trial of Endoluminal High-Dose-Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management

Inclusion Criteria

• •Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus
• •Prior pelvic EBRT
• •Age \> or = to 18 years
• •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 5-FU or capecitabine
• •* Will not undergo surgery for the study disease
• •* Able to receive HDR brachytherapy ANC ≥ 1.5 cells/mm3 and PLT ≥100,000/mm3
• •Adequate Renal function: Creatinine \<1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50cc/min
• •Adequate Hepatic functions: 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)
• •AST or ALT \<3xULN, or \<5x 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