Carcinoma of the cervix and the use of hyperbaric oxygen with radiotherapy: a report of a randomised controlled trial

Background and purpose: A randomised controlled trial of hyperbaric oxygen in the radiotherapy of Stage IIb and III carcinoma of cervix was performed between 1971 and 1980. Apart from an abstract giving an interim report in 1 977, results have not been published. Material and methods: In a four arm study, 335 patients were randomised to treatment in 10 or 28 fractions, in hyperbaric oxygen or in air. Data is av ailable concerning 327 cases and this has been analysed. Results: There was no advantage in tumour control shown with the use of hyp erbaric oxygen. There was evidence for an increase in late radiation morbid ity when treatment was given in hyperbaric oxygen rather than in air and wh en, using 10 fractions, a total dose of 45 rather than 40 Gy was achieved. For late intestinal morbidity, the fractionation sensitivity (alpha/beta ra tio) was calculated to be 4.3 Gy and the steepness of the dose response cur ve (gamma(50)) to be 2.6. Conclusions: Hyperbaric oxygen gave no benefit in the treatment of patients with stage IIb and III carcinoma of the cervix treated with radiotherapy u sing two fractionation regimes. Important data regarding late radiation mor bidity has been revealed. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.