RANDOMIZED CONTROLLED TRIAL OF POSTOPERATIVE RADIOTHERAPY AND SHORT-TERM TIME-SCHEDULED 5-FLUOROURACIL AGAINST SURGERY ALONE IN THE TREATMENT OF DUKE-B AND DUKE-C RECTAL-CANCER

Background The purpose of the present study was to investigate whether a 1-month regimen of postoperative radiotherapy combined with 5-fluor ouracil could reduce the local recurrence rate and improve survival in patients with Dukes B and C rectal cancer. Methods One hundred and fo rty-four patients were randomized to surgery alone or surgery combined with postoperative radiotherapy (46 Gy) and bolus 5-fluorouracil 30 m in before six of the radiotherapy fractions. One hundred and thirty-si x patients were eligible. Results The adjuvant treatment was well tole rated. After an observation time of 4-8 years, patients in the adjuvan t treatment group had a cumulative local recurrence rate of 12 per cen t compared with 30 per cent in the group that had surgery only (P = 0. 01). The 5-year recurrence-free and overall survival rate was 64 per c ent in the adjuvant group compared with 46 per cent (P = 0.01) and 50 per cent (P = 0.05) respectively in the surgery group. The adjusted re lative risk of recurrence and death for the adjuvant group was 0.48 (9 5 per cent confidence interval 0.28-0.82) and 0.56 (0.33-0.94) respect ively. Conclusion The 1-month postoperative combination regimen improv ed treatment results in patients with Dukes B and C rectal cancer, id terms of local recurrence rate, recurrence-free survival and overall s urvival, without serious side-effects.