RANDOMIZED STUDY ON PREOPERATIVE RADIOTHERAPY IN RECTAL-CARCINOMA

Background: A population based prospective randomized trial on preoper ative radiotherapy in operable rectal cancer was conducted in Stockhol m, Sweden, Five hundred fifty-seven patients from 12 institutions were included with histologically proven, clinically resectable rectal ade nocarcinoma. Patients planned for local excision or previously irradia ted to the pelvis were excluded. Methods: A total of 272 patients were allocated to preoperative irradiation with 25 Gy in five cycles durin g 5-7 days to the rectum and the pararectal tissues (RT+ group) and 28 5 patients were allocated to surgery only (RT- group). The median foll ow-up time was 50 months. No patient was lost to follow-up. Surgery wa s considered curative in 479 patients (86%). Results: Locoregional rec urrence occurred in 10% of the patients in the RT+ group versus 21% in the RT- group (p <0.01). Among the curatively operated patients, dist ant metastases occurred in 19% in the RT+ group versus 26% in the RT- group (p = 0.02). The overall survival was improved in the irradiated patients (p = 0.02). Postoperative complications were more common afte r irradiation but were usually mild. The postoperative mortality was l ow in both groups. Conclusion: Preoperative short-term, high-dose radi otherapy as given in this trial reduces the risk of local and distant recurrence and improves survival after curative surgery for rectal car cinoma.