Irradiation, chemotherapy and surgery in esophageal cancer: a randomized clinical study. The first Scandinavian trial in esophageal cancer.

In a randomized trial, irradiation alone (35 Gy) or irradiation (30 Gy) and bleomycin was given as preoperative treatment of esophageal cancer. In inoperable patients, a split course of irradiation alone (63 Gy) or irradiation (55 Gy) and bleomycin was given. Bleomycin doses were 5 mg i.m. 1/2-1 h before each irradiation dose. No benefit was obtained by addition of bleomycin to irradiation concerning survival or palliation of dysphagia. No benefit of bleomycin was seen either in any subgroup of patients according to different primary tumour classifications, histopathological gradings or localizations of tumour. In patients with advanced/metastatic disease, bleomycin and adriamycin treatment gave a significantly longer survival than bleomycin alone. It was shown that the presence of T1 tumours was a significant prognostic factor for long-term survival and that performing a radical operation was a significant advantage for a longer survival. Female patients treated with irradiation with or without bleomycin survived significantly longer than males, but in operable patients there was no significant difference between the two sexes with regard to survival.

RCT Entities:   Population Interventions Outcomes