A randomized phase II study of TS-1 plus cisplatin versus vinorelbine plus cisplatin with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (LA-NSCLC): WJOG 5008L.

7512 Background: Cisplatin-based chemotherapy and concurrent radiotherapy is the standard treatments for LA-NSCLC. Thistrial evaluated two experimental regimens of chemotherapy with concurrent radiotherapy. Methods: Eligible patients with unresectable stage III NSCLC, 20 to 74 years of age, and ECOG PS of 0–1 were randomized to either Arm SP, S-1 (40 mg/m2/dose per oral, b.i.d, on days 1-14) and cisplatin (60 mg/m2 on day 1) repeated every 4 weeks or Arm VP, vinorelbine ( 20mg/m2 on day 1, 8) and cisplatin (80 mg/m2on day) repeated every 4 weeks with early concurrent thoracic radiotherapy of 60 Gy at 2 Gy per daily fraction. The primary endpoint was overall survival rate at 2-year (2yr-OS). A pick-the-winner design was used to identify the treatment regimen most likely to be superior. The planned sample size was 55 patients per arm, assuming in each arm that the null hypothesis for 2yr- OS was 50% versus an alternative hypothesis for 65% with one-sided alpha of 0.10 and power of 80% (Study ID: UMIN0000024...