Prospective randomized trial of surgery combined with preoperative and postoperative radiotherapy for rectal carcinoma

Objective To assess the effect of surgery combined with preoperative and postoperative radiotherapy ("sandwich" treatment) in rectal carcinoma. Methods From October 1990 to January 2002, 260 patients with stage Ⅱ (117 patients) and stage Ⅲ (143 patients) rectal carcinoma were randomly divided into three groups: "sandwich" group (92 patients, group A), postoperative radiotherapy group (98 patients, Group B) and operation group (70 patients, Group C). The preoperative accelerated hyperfractionation (15 Gy/6f/3d) was given for "sandwich" group which was followed by conventional postoperative fractionation (DT 35 - 40 Gy/3.5 - 4 weeks). Patients in Group B were given postoperative radiotherapy (Dr 50 Gy/5 weeks). Patients treated with surgery alone served as control. Results The local recurrence rates of Group A, B and C were 5.4% (5/92), 16.3% (16/98) and 64.3% (45/70), respectively (X2 =5.726, P=0.017); and the distant metastasis rates were 6.5% (6/92), 28. 6%(28/98) and 31.4%(22/70), respectively (X2 =15. 703, P= 0. 001). The 3-ycar survival rate was 86. 9%(80/92), 62.2%(61/98) and 51.4%(36/70), respectively (X2 =15. 141, P=0. 001). The 5-year survival rate was 68. 5%(63/92), 54.1%(54/98)and 41.4%(29/70), respectively (X2 =4. 218, P=0.04). The Ⅰ and Ⅱ grades of radiation entero-colitis in Group A and Group B were 7.6% (7/92) and 6.1% (6/98), respectively (X2 = 0. 164, P= 0. 685). Conclusion Surgery combined with preoperative and postoperative radiotherapy can improve the survival rate and reduce the local recurrence rate in rectal carcinoma patients with stage Duke's B (Ⅱ) and C (Ⅲ).