Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Medical Center
• Treatments: Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria

• Histologically proven adenocarcinoma of the rectum with no distant metastases.

• T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT

• The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination.

• No prior chemotherapy or pelvic irradiation.

• ECOG performance status 0-1

• Age 18 to 70 years

• ANC >= 1500/mm3 and platelets >= 100,000/mm3

• Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN

Exclusion Criteria

• Pregnant or lactating females; patients not practicing active contraception while sexually active.

• No other serious medical condition

• A psychiatric disorder that would prohibit the subject from participating fully.

• Peripheral neuropathy > grade 1

• History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma.

• HIV positive patients