Patients
tumor, Dukes’ A, cancer, Dukes’ B3, C stage, Dukes’ B2 cancer, Dukes’ B3, C
CANCER, TUMOR, PATHOLOGY, DISEASE CHARACTERISTIC
The final accrual for the study was 859 patients. Of the 859 enrolled patients, 4 were not randomized after registration and were excluded from all analyses. A total of 855 patients were randomized (step 1): 427 to arm A (perioperative 5-FU) and 428 to arm B (no perioperative chemotherapy). Figure CONSORT diagramOf the 855 randomized patients, 17 had no pathology reports (12: no cancer at surgery; 3: no resection; and 2: no data). For the 838 patients with pathologic data, 252 were Dukes’ A, B1, or D stage, which removed them from the study. The remaining patients were 289 with Dukes’ B2 and 314 with Dukes’ B3 or C stage disease.A total of 240 patients with Dukes’ B2 cancer were registered to step 2 (123 arm A, 117 arm B). Two hundred thirty-eight patients with Dukes’ B3, C stage registered to step 2 (114 arm A, 124 arm B) and were to receive adjuvant leucovorin/levamisole and 5-FU.Baseline demographics and tumor characteristics of the patients with Dukes’ B3, C and Dukes’ B2 stage colon cancer are listed by treatment arm in Table Baseline demographic and disease characteristics in ITT patients