Phase III study of surgery (S) versus definitive concurrent chemoradiotherapy boost (def ccCRTx-BOx) in patients (pts) with operable (OP+) stage IIIA(N2)/selected IIIb (sel IIIB) non-small cell lung cancer (NSCLC) following induction (IND) chemotherapy (CTx) and concurrent CRTx (ESPATUE).

7510 Background: Def ccCRTx or ccCRTx + S are accepted therapies (Tx) for OP+ stage IIIA(N2) NSCLC (Albain 2009). Our multicenter phase-II showed efficacy of CTx + ccCRTx + S in IIIA(N2) / sel IIIB (CISTAXOL: Eberhardt 2013). Here we compared S with ccCRTx-BOx in OP+ stage III NSCLC following IND. With 246/500 planned pts (1/04-8/12) trial closed for slow accrual + futility. Here we report final analysis (29-Jan-2014). Methods: Pathologically proven OP+ IIIA(N2) / sel IIIB NSCLC pts, adequate organ function / functional OP+, received IND CTx (3 cycles CDDP/taxol) and ccCRTx to 45 Gy (1.5Gy bid/cc CDDP/vinorelbine). Pts were reevaluated in last week ccCRTx (PET-CT) and discussed by multidisciplinary board. OP+ pts were randomized (rand) to def ccCRTx-BOx risk adapted to 65/71 Gy (arm A) or S (arm B). Primary endpoint: overall survival (OS). Results: 246 pts (70 F 176 M; T1-3N2 75 T4N0-1 80 T4N2/anyT N3 91; age 59 (33-74); SQC 95 ADC 107, other 44) enrolled at 5 centers. 245 started IND, 161/246 OP+ pts (65...