A total of 246 patients were randomly allocated to one of two groups: adult patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer (combination group) or FTD-TPI alone (FTD-TPI group). The median overall survival in the combo group was 10.8 months and 7.5 months in the FTD-TPI group. The median progression-free survival in the combo group was 5.6 months and 2.4 months in the FTD-TPI group.