Study Design
tumor, Dukes’ B3, Dukes’ C, Dukes’ A, Dukes’, Dukes’ B2 (, Dukes’ B1 (stage I
DUKES, DISEASE, PATHOLOGY, TUMOR
This prospective randomized phase III trial was conducted by the NCI Intergroup: ECOG, SWOG, NSABP, and CALGB. The study was randomized but not blinded and there was no placebo control. The trial included two steps. In step 1, patients were equally randomized to receive perioperative infusional 5-FU (arm A) or no perioperative 5-FU (arm B). Treatment assignment for patients at all institutions was obtained from the Central Randomization Desk at the ECOG Operations Office. The treatments were assigned using permutated blocks with dynamic balancing within main institutions and their affiliate networks. No stratification factors were used in randomization. If at surgery the patient’s disease was found to be metastatic, the patient was taken off protocol. All other patients randomized to arm 1 initiated perioperative chemotherapy.When the surgical pathology became available, patients whose tumor stage was Dukes’ A (AJCC stage I, T1N0) or Dukes’ B1 (stage I, T2N0), were removed from the study and the chemotherapy infusion stopped. Survival data were collected. Patients whose tumor stage was Dukes’ B2 (AJCC stage IIA,T3N0 or IIB,T4aN0), Dukes’ B3 (stage IIC,T4b), or Dukes’ C (stage III), continued with their assigned treatment and were reregistered to step 2. The Dukes’ B2 patients would not receive further adjuvant chemotherapy, while the Dukes’ B3 and C patients would receive subsequent adjuvant chemotherapy per standard of care (Fig. Study schema