LOCAL RECURRENCE RATE IN A RANDOMIZED MULTICENTER TRIAL OF PREOPERATIVE RADIOTHERAPY COMPARED WITH OPERATION ALONE IN RESECTABLE RECTAL-CARCINOMA

Objective: To find out whether short-term high-dose preoperative radio therapy can reduce local recurrence rate without increasing postoperat ive mortality in patients with resectable rectal cancer. Design: Rando mised trial. Setting: Nationwide Swedish multicentre trial. Subjects: From March 1987 to February 1990, 1168 patients were randomised. In ea ch group, 454 patients had curative surgery. Interventions: Patients w ere allocated to preoperative irradiation (25 Gy in five fractions in one week) followed by operation within a week, or to surgery alone. Ma in 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 cu rative 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) a nd Dukes' stage C 18% (31/177) and 37% (86/230), (p < 0.001), respecti vely. Conclusion: Preoperative irradiation with a short-term high-dose regimen reduces the local recurrence rate by roughly 65% after a mini mum follow-up of two years. The influence on survival will be analysed after a minimum of five years follow-up.