NSABP C-03 — National Surgical Adjuvant Breast and Bowel Project Protocol C-03

Phase 3 · 1993 · Colon Cancer

Design

Randomized phase 3 trial comparing postoperative adjuvant leucovorin-modulated fluorouracil (5-FU/LV) versus MOF (semustine, vincristine, and fluorouracil) in resected primary colon cancer.

Population

Patients with resected Dukes' B and C (stage II and III) primary colon cancer.

Primary Endpoint

Disease-free survival

Key Result

Leucovorin-modulated fluorouracil significantly improved 3-year disease-free survival to 73% versus 64% for MOF and 3-year overall survival to 84% versus 77% (30% reduction in odds of recurrence and 32% reduction in mortality odds).

Guideline Impact

Established 5-FU/leucovorin as adjuvant standard for resected colon cancer