Objective: To find out whether short-term high-dose preoperative radiotherapy can reduce local recurrence rate without increasing postoperative mortality in patients with resectable rectal cancer.
Design: Randomised trial.
Setting: Nationwide Swedish multicentre trial.
Subjects: From March 1987 to February 1990, 1168 patients were randomised. In each group, 454 patients had curative surgery.
Interventions: Patients were allocated to preoperative irradiation (25 Gy in five fractions in one week) followed by operation within a week, or to surgery alone.
Main outcome measures: Postoperative morbidity and mortality, and local recurrence rate.
Results: After a minimum follow-up of two years, 9% (51/553) of the patients in the irradiated group who had had the tumour resected had developed a local recurrence, compared with 24% (131/557) in the surgery alone group (p < 0.001). In patients who underwent curative operations, the local recurrence rates were 7% (33/454) and 20% (93/454), respectively (p < 0.001). The corresponding figures for all patients with Dukes' stage tumours were: A 3% (6/181) and 9% (14/154) (p = 0.04); Dukes' stage B 7% (14/195) and 18% (31/173), (p < 0.01) and Dukes' stage C 18% (31/177) and 37% (86/ 230), (p < 0.001), respectively.
Conclusion: Preoperative irradiation with a short-term high-dose regimen reduces the local recurrence rate by roughly 65% after a minimum follow-up of two years. The influence on survival will be analysed after a minimum of five years followup.