Local recurrence rate in a randomised multicentre trial of preoperative radiotherapy compared with operation alone in resectable rectal carcinoma. Swedish Rectal Cancer Trial.

OBJECTIVE

To find out whether short-term high-dose preoperative radiotherapy can reduce local recurrence rate without increasing postoperative mortality in patients with resectable rectal cancer.

DESIGN

Randomised trial.

SETTING

Nationwide Swedish multicentre trial.

SUBJECTS

From March 1987 to February 1990, 1168 patients were randomised. In each group, 454 patients had curative surgery.

INTERVENTIONS

Patients were allocated to preoperative irradiation (25 Gy in five fractions in one week) followed by operation within a week, or to surgery alone.

MAIN OUTCOME MEASURES

Postoperative morbidity and mortality, and local recurrence rate.

RESULTS

After a minimum follow-up of two years, 9% (51/553) of the patients in the irradiated group who had had the tumour resected had developed a local recurrence, compared with 24% (131/557) in the surgery alone group (p < 0.001). In patients who underwent curative operations, the local recurrence rates were 7% (33/454) and 20% (93/454), respectively (p < 0.001). The corresponding figures for all patients with Dukes' stage tumours were: A 3% (6/181) and 9% (14/154) (p = 0.04); Dukes' stage B 7% (14/195) and 18% (31/173), (p < 0.01) and Dukes' stage C 18% (31/177) and 37% (86/ 230), (p < 0.001), respectively.

CONCLUSION

Preoperative irradiation with a short-term high-dose regimen reduces the local recurrence rate by roughly 65% after a minimum follow-up of two years. The influence on survival will be analysed after a minimum of five years followup.