LBA4013 Background: 5FU regimens have been suggested to be effective in the adjuvant setting after LMCRC. Irinotecan (IRI) combined with infused 5FU regimens showed improvement in outcome of advanced colorectal cancer. The aim of this international, randomized trial was to compare the adjunction of IRI to FUFA in this setting. Methods: Main inclusion criteria: complete surgical resection (R0) of exclusively liver metastases with no prior treatment for metastatic disease. Patients were randomized to either: arm A, FA 400mg/m2/2h iv, 5FU 400mg/m2/2h bolus, followed by 2400 mg/m2/46h continuous infusion q2w for 12 cycles, or arm B, FUFA+IRI 180mg/m2/d1. The primary endpoint is disease-free survival (DFS). The analysis was planned after at least 147 events were observed and a minimum of 1 year of follow up in order to detect a hazard ratio of 0.64 (alpha=5%, power=85%). Secondary endpoints include safety and overall survival. Results: Between 12/2001 and 7/2006, 321 pts from 15 countries were randomized. The ...