NSABP C-04 — Clinical Trial to Assess the Relative Efficacy of Fluorouracil and Leucovorin, Fluorouracil and Levamisole, and Fluorouracil, Leucovorin, and Levamisole in Patients With Dukes' B and C Carcinoma of the Colon: Results From NSABP C-04

Phase 3 · 1999 · Colon Cancer

Design

Randomized trial comparing adjuvant 5-FU/leucovorin, 5-FU/levamisole, and 5-FU/leucovorin/levamisole after colon resection.

Population

Patients with Dukes' B and C (stage II-III) carcinoma of the colon after curative surgery.

Primary Endpoint

Disease-free survival and overall survival

Key Result

5-FU/leucovorin showed a trend to better 5-year disease-free survival (65% vs 60%; P=0.04) and overall survival vs 5-FU/levamisole, with no added benefit from levamisole.

Guideline Impact

5-FU/leucovorin adopted as adjuvant standard in colon cancer guidelines