A randomized trial of postoperative radiotherapy versus observation in stage II and III renal adenocarcinoma. A study by the Copenhagen Renal Cancer Study Group.

Between 1979 and 1984 the Copenhagen Renal Cancer Study Group randomized 72 patients nephrectomized for stages II and III renal adenocarcinoma in a prospective study of postoperative radiotherapy versus observation. Radiotherapy was 50 Gy in 20 fractions to the kidney bed, ipsi- and contralateral lymph nodes. 7/72 were excluded from further analysis because of major protocol violations. 33/65 were in stage II, 32/65 in stage III. Relapse was found in 31/65 = 48% during the follow-up period without any difference between the two groups. 12/27 = 44% had significant complications from stomach, duodenum or liver, median 5 mo., range 1-44 mo. after radiotherapy. In 5/27 = 19% did the postirradiatory complications contribute to the death of the patients. Patients with stage II tumours survived significantly better than those with stage III tumours (p less than 0.05), but no significant differences in survival could be demonstrated between patients randomized to postoperative radiotherapy or observation. It is concluded that postoperative radiotherapy as given in the present study is without any beneficial effect on relapse rate and survival. Moreover, the treatment is associated with an unacceptable complication rate.

RCT Entities:   Population Interventions Outcomes