MOSAIC — Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer

Phase 3 · 2004 · Colon Cancer

Design

Randomized adjuvant trial comparing FOLFOX4 (oxaliplatin added to infusional 5-FU/LV) versus 5-FU/LV alone after resection.

Population

Patients with completely resected stage II or III colon cancer.

Primary Endpoint

disease-free survival (DFS)

Key Result

6-year OS 78.5% vs 76.0% overall and stage III DFS benefit (HR ~0.78); 5-year DFS 73.3% vs 67.4%.

Guideline Impact

NCCN category 1 adjuvant therapy for stage III colon cancer