DOUBLE-BLIND CONTROLLED CLINICAL-TRIAL OF RADIATION PLUS RAZOXANE (ICRF-159) VERSUS RADIATION PLUS PLACEBO IN TREATMENT OF HEAD AND NECK CANCER

Ninety patients with salivary gland or squamous cell tumours of the head and neck region presenting to two centres were included in a double blind controlled clinical trial of radiation plus razoxane versus radiation plus placebo. The patients were paired according to treatment centre, sex, tumour site and tumour stage, one member of a pair receiving razoxane and one placebo during radiotherapy. The dose of razoxane administered was 125 mg in the morning and 62.5 mg in the evening of each day of radiation. The treatments were assessed by comparing the tumour response of pairs of patients and the preferences for treatment type analyzed sequentially on the plan described by Bross. Of the 18 pairs eligible for analysis at the completion of the trial, one showed a preference for the treatment radiation plus razoxane, nine for the treatment radiation plus placebo, four showed no preference for either treatment and four had not been assessed. The conclusion drawn from the sequential analysis of the results is that razoxane, in the dose and schedule employed, has a deleterious effect on the response of head and neck tumours to radiation. Excluding a positive placebo action, the possibility of a radioprotective effect of razoxane is discussed and the importance of reconsidering the dose and timing of administration of the drug in future clinical studies is emphasized. © 1978.