Between October 1998 and January 2001, 2246 patients were enrolled at 146 centers in 20 countries:
1123 patients were randomly assigned to receive FL plus oxaliplatin and 1123 to receive FL without
oxaliplatin. Of these patients, 1108 received at least one cycle of FL plus oxaliplatin and 1111 received at least one cycle of FL. The patients’ characteristics were well matched in the two groups (Table 1). In both groups, 60 percent of the patients had stage III disease and 40 percent had stage II disease. The overall median time between surgery and the start of chemotherapy was 5.7 weeks (range, 1.1 to 17.0).