Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage
II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated
with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce
distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated
by benefits demonstrated in stage III colon cancer.
Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and
RT followed by total mesorectal excision (TME) and adjuvant
PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant
combination chemotherapy with radiation works in treating patients undergoing surgery for
rectal cancer.