Double blind controlled clinical trial of radiation plus razoxane (ICRF 159) versus radiation plus placebo in the treatment of head and neck cancer

Adjuvant chemotherapy in head and neck cancer

“…Analysis of survival Exclusion of treated patients Nine reports excluded some treated patients from the final analysis (Cachin et al, 1977;Fazekas et al, 1980;Fu et al, 1987;Head and Neck Contracts Program, 1987;Hussey & Abrams, 1975;Lo et al, 1976;Martin et al, 1986;Stefani & Chung, 1980;Taylor et al, 1985). Out of a total of 2012 patients in these nine trials 183 patients were excluded from the analysis (9.1%).…”

“…Several trials have been excluded from the analysis for the following reasons: first, several well designed studies do not report the survival rate (Bakowski et al, 1978;Fletcher et al, 1963;Kapstad et al, 1978;Richards & Chambers, 1969;Shanta & Krishnamurthi, 1980); second, one study was not randomised, as the control arm consisted of those rejected for radical treatment ; third, one trial did not include an arm receiving conventional treatment only (SECOG, 1986); fourth one trial (Shanta & Krishnamurthi, 1980) reported diseasefree survival only, and coud therefore not be analysed for mortality.…”

“…This left 23 randomised controlled trials with survival data (Arcangeli et al, 1983;Cachin et al, 1977;Ervin et al, 1987;Fazekas et al, 1980;Fu et al, 1987;Gollin et al, 1972;Gupta et al, 1987;Head and Neck Contracts Program, 1987;Holoye et al, 1985;Hussey & Abrams, 1975;Knowlton et al, 1975;Lo et al, 1976;Martin et al, 1986;Nissenbaum et al, 1984;Pearlman et al, 1985;Petrovich et al, 1981;Rentschler et al, 1987;Schuller et al, 1988;Stefani et al, 1971;Stefani & Chung, 1980;Stell et al, 1983;Stolwijk et al, 1983;Taylor et al, 1985;Toohill et al, 1987;Vermund et al, 1985 Gollin et al (1972) and a subgroup of patients with tumours of the oral cavity and oropharynx, with additional patients, was later reported by Lo et al (1976). The data for tumours of the mouth and oropharynx are taken from the latter paper, and those for other sites from the former, but the two are otherwise treated as one trial.…”

ICRF 159 Plus Radiation Versus Radiation Therapy Alone in Cervical Carcinoma

“…A randomized trial on 40 patients with inoperable lung carcinoma failed to demonstrate any difference in survival of the combined therapy group compared with radiotherapy alone [18]. Questinonable effects were reported on metastases from breast carcinoma [11], and in head and neck cancer ICRF 159 was reported as having deleterious effects [19].…”

Reduced survival with radiotherapy and razoxane compared with radiotherapy alone for inoperable lung cancer in a randomised double-blind trial

“…We are aware of reports of 2 previous doubleblind, placebo-controlled trials of razoxane combined with radiotherapy by Bakowski et al (1978) and Belloni et al (1983). One reported no benefit in operable cervical cancer, the other reported deletrious effects in head and neck cancer.…”