[CHARTWEL-Bronchus (ARO 97-1): a randomized multicenter trial to compare conventional fractionated radiotherapy with CHARTWEL radiotherapy in inoperable non-small-call bronchial carcinoma].

BACKGROUND: The CHART-bronchus trial sponsored by the Medical Research Council showed an improvement in survival of 10% compared to conventional fractionation to 60 Gy when patients with inoperable non-small-cell lung cancer (NSCLC) were treated with CHART to 54 Gy. At present it is not known whether this survival advantage holds when the dose of conventional treatment is increased and whether CHART can be replaced by the more practicable CHARTWEEL (CHART-weekend less). PROTOCOL OF THE TRIAL: A randomized multicenter trial of definite radiotherapy in locally advanced inoperable NSCLC was designed (ARO 97-1, Arbeitsgemeinschaft Radioonkologie der Deutschen Krebsgesellschaft). Conventional fractionation to 66 Gy (5 weekly fractions of 2 Gy) is compared with CHARTWEEL to 60 Gy (15 weekly fractions of 1.5 Gy, Monday to Friday, interval between fractions > or = 6 hours, overall treatment time 2.5 weeks). The main endpoint of the trial is overall survival. It was calculated that an entry of 665 patients is needed to detect an improvement in 2-year survival of 10%, the actual time is estimated to be 5 years or less. The trial was activated on 1.9.1997.