Randomized, controlled trial of lateral node dissection vs. nerve-preserving resection in patients with rectal cancer after preoperative radiotherapy

PURPOSE: The effectiveness of preoperative radiation therapy for advanced l ower rectal carcinoma to preserve the function of pelvic organs and reduce local recurrences was examined in a prospective, randomized, controlled stu dy. METHODS: Fifty-one patients with a diagnosis of localized and resectabl e adenocarcinoma. of the lower rectum undergoing 50 Gy of preoperative radi otherapy were recruited into the trial between April 1993 and March 1995. T he patients were randomly allocated to complete autonomic nerve-preserving surgery without lateral node dissection (D1), or surgery with dissection of the lateral lymph nodes including autonomic nerves (D2) followed by oral a dministration of carmofur for one year. RESULTS: No difference was observed in either survival or disease-free survival between D1 and D2 groups. Ther e was no difference between the two groups in terms of recurrence rate. A s ignificant difference was observed in urinary and sexual function (P = 0.02 and 0.02, respectively) one year after surgery between D1 and D2 groups. C ONCLUSION: This study suggests that lateral node dissection is not necessar y in terms of curability for patients with advanced carcinoma of the lower rectum who undergo preoperative radiotherapy.