Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer - Prospective randomised trial with standard operative and histopathological techniques

Objective: To document local recurrence in primary rectal cancer when stand ardised techniques of surgery, radiotherapy, and pathology are used, and to investigate whether the local recurrence rate after total mesorectal excis ion permits the omission of adjuvant short term preoperative radiotherapy. Design: Prospective randomised study. Setting: Dutch (n = 80), English (n = 1), German (n = 1), Swedish (n = 9), and Swiss (n = 1) hospitals. Subjects: The first 500 randomised Dutch patients with primary rectal cance r. Main outcome measures: Local recurrence, survival, operation-related factor s, specific pathological tumour characteristics, short and long term morbid ity, and quality of life. Results: Between January 1996 and April 1998, 871 Dutch and 94 other patien ts were randomised. Our feasibility analysis shows that cooperation between and within the participating disciplines goes well. With regard to the sur gical part, this can be confirmed by the large number of operations attende d by consultant surgeons (58%). The number of abdominoperineal resections a ppeared to be low (30%), as did the percentage of lateral margins involved (13%). The rate of adverse effects of radiotherapy was acceptable. Apart fr om a larger operative blood loss and a higher infective complication rate i n the irradiated group, no significant differences were found with regard t o morbidity and mortality between the randomised groups. Conclusions: The accrual of our trial is going well and it is feasible; sho rt term preoperative radiotherapy is safe even in combination with TME.