A randomised phase III study of accelerated or standard fraction radiotherapy with or without concurrent carboplatin in inoperable nonsmall cell lungcancer: final report of an Australian multi-centre trial

Purpose: To investigate the effects separately and together of (a) shorteni ng overall treatment time and (b) giving concurrent carboplatin in patients having radical radiotherapy for inoperable non-small-cell lung cancer (NSC LC). Patients and methods: Between April 1989 and May 1995, 204 patients with me dically inoperable or technically unresectable NSCLC localised to the prima ry site and regional lymph nodes were randomised to receive one of four tre atments using a 2 x 2 factorial design: standard radiotherapy, 60 Gy in 30 fractions in 6 weeks (R6); accelerated radiotherapy, 60 Gy in 30 fractions in 3 weeks (R3); standard radiotherapy as in R6 with carboplatin 70 mg/m(2) /day for 5 days during weeks 1 and 5 of radiotherapy (R6C); accelerated rad iotherapy as in R3 with carboplatin 70 mg/m(2)/day for 5 days during week 1 of radiotherapy (R3C). Results: The estimated median survival of all randomised patients was 15.7 months and estimated 2-year survival was 31%. The longest survival was seen in patients randomised to R6C (median 20.3 months, 41% surviving at 2 year s) but there were no statistically significant differences between treatmen t arms or treatment factors (carboplatin versus no carboplatin, accelerated versus conventional radiotherapy). Haematological toxicity was significant ly greater in patients treated with carboplatin and oesophageal toxicity wa s significantly greater and more protracted in patients treated with accele rated radiotherapy. Conclusions: This study failed to show a significant survival advantage for any of the treatment arms or factors. Halving overall treatment time resul ted in significantly greater oesophageal toxicity with no suggestion of a s urvival advantage. (C) 1999 Elsevier Science Ireland Ltd. All rights reserv ed.