Short-term preoperative radiotherapy for adenocarcinoma of the rectum. An interim analysis of a randomized multicenter trial. Stockholm Rectal Cancer Study Group.

Between 1980 and 1985, 694 patients with clinically resectable rectal adenocarcinoma entered a controlled clinical trial of radiotherapy (25 Gy over 5-7 days) prior to surgery, as compared with surgery alone. At a median follow-up time of 34 months, the incidence of pelvic recurrence among 545 patients operated on "for cure" was significantly reduced in the radiotherapy group (p less than 0.01). The relative reduction rate was similar among patients with Dukes' A, B, and C tumors. No significant differences between the treatment groups were observed with regard to frequency of distant metastasis or survival. The postoperative mortality--defined as death within 30 days of surgery--was 7% in the radiotherapy group as compared to 2% in the group randomized to surgery only (p less than 0.01). This mortality mainly occurred among patients aged above 75 years, and the difference between the groups may have been due to the fact that the irradiated volume was fairly large. In younger patients, there was no significantly increased mortality with radiotherapy.

RCT Entities:   Population Interventions Outcomes