Chemotherapy as an adjuvant to surgery for colorectal cancer.

A combined intraoperative and postoperative adjuvant program of 5 minus Fluorouracil (5 FU) for patients undergoing "curative" resection for adenocarcinoma of the colon and rectum was initiated as a randomized clinical trial in January 1968. Patients at the Medical College of Virginia and the University of Virginia were randomly assigned to an intraluminal 5 FU or intraluminal control (Saline) group and were so treated at the time of surgical resection if findings at operation indicated that all gross neoplastic disease could be resected. Patients with operative findings denoting incurability were eliminated from the study after surgical exploration. Those patients receiving intraluminal 5 FU (30mg/kg) received intravenous 5 FU (10mg/kg) on each of the two first postoperative days and 5 subsequent postoperative courses of oral 5FU (90 mg/kg in each 18 day course) over a one year period. By December 31, 1973 (6 years) 156 patients undergoing "curative" resection were entered into the study. SU therapy with the control or "No Treat" group reveal no significant benefit from this intensive adjuvant course of 5 FU thus far. Continued assessment of these patient groups and their subgroups will be required to develop confidence in these findings but the data thus far suggest no potential benefit from this particular adjuvant program.

RCT Entities:   Population Interventions Outcomes