3523 Background: In a large phase III study (X-ACT) in stage III colon cancer, adjuvant capecitabine was at least equivalent to bolus 5-FU/LV for disease-free survival (DFS). In the MOSAIC trial, oxaliplatin + 5-FU/LV (FOLFOX4) resulted in superior DFS compared to 5-FU/LV, and has recently been approved for adjuvant therapy. As in metastatic colorectal cancer, capecitabine should be considered as an alternative to i.v. 5-FU in combination with oxaliplatin in the adjuvant setting. Therefore, we compared the safety and efficacy of XELOX to bolus 5-FU/LV (the standard regimen at the start of the study) as adjuvant therapy for stage III colon cancer. Methods: Pts with resected stage III colon cancer received XELOX (capecitabine 1000mg/m2 bid d1–14 + oxaliplatin 130mg/m2 d1, q3w x8) or i.v. bolus 5-FU/LV (Mayo Clinic, LV 20mg/m2 + 5-FU 425mg/m2 d1–5, q4w x6; or Roswell Park [RP], LV 500mg/m2 + 5-FU 500mg/m2 d1, w1–6 in 8w cycles x4). Results: 1719 of the 1886 pts randomized between Apr03 and Sep04 are evaluabl...