Bleomycin and radiation therapy in squamous cell carcinoma of the upper aero-digestive tract: a phase III clinical trial.

A group of 222 consecutive patients admitted with squamous cell carcinoma of the upper aero-digestive tract were studied in a prospectively randomized and stratified clinical trial. One-half of the patients received bleomycin injected intramuscularly 1 hour before the radiation treatment daily for 5 days a week; the other half received radiation therapy without the added chemotherapy. The total dose of radiation in both groups was about the same, and was given with curative intent even to the patients with advanced tumors who constituted the majority in both groups. Interstitial radiation as boost therapy or surgery was added in patients with residual tumor if the lesions were considered operable and the patient's condition would allow surgery. The addition of bleomycin did not increase the combined local and regional tumor control rates nor did it improve the survival, but did significantly increase the morbidity and the complication rate.