The evidence supporting this protocol is provided by a phase 3 multicentre randomised trials involving 417 patients with limited stage SCLC comparing hyperfractionated accelerated radiotherapy with once-daily radiotherapy in patients receiving concurrent cisplatin and etoposide.r
Between 1989 and 1992, 211 patients were randomised to receive 45Gy in twice daily 1.5Gy fractions over 3 weeks and 206 patients were randomised to receive 45Gy in once daily fractions of 1.8Gy over 5 weeks. Both arms were delivered with 4, three-weekly cycles of concurrent cisplatin and etoposide chemotherapy. Cisplatin dose was 60mg/m2 on D1 and etoposide 120mg/m2 D1-3 of each cycle.
The primary end point was overall survival.
After a median follow up of almost 8 years, the median overall survival was 23 vs. 19 months, and local failure was 36% vs 52%, both in favour of twice-daily concurrent chemoradiotherapy.