Preoperative short-term radiation therapy in operable rectal carcinoma: A prospective randomized trial

From 1980 to 1987, 849 patients with clinically resectable rectal adenocarcinoma were randomized into a controlled clinical trial of radiation therapy (2500 cGy over 5 to 7 days) before surgery versus surgery alone. At a median follow-up time of 53 months (range, 8 to 90) the incidence of pelvic recurrence among 679 curatively operated upon patients was significantly lower among those allocated to radiation therapy (P less than 0.01). A reduction was observed in all Dukes' stages. No significant difference between the treatment groups was observed with regard to frequency of distant metastases or overall survival. Among all randomized patients as well as the radically operated patients the recurrence-free interval, i.e., time to local recurrence or distant metastasis, was significantly prolonged in the preoperatively irradiated group. The radically operated patients also had a significantly prolonged survival related to rectal cancer (P = 0.05). The postoperative morbidity, however, was significantly higher among irradiated patients. The postoperative mortality was 8% in the radiation therapy group compared to 2% in the surgery alone group (P less than 0.01).