Surgery for NSCLC stages T1-3N2M0 having preoperative pathologically verified N2 involvement: A prospective randomized multinational phase III trial by the Nordic Thoracic Oncology Group.

7504 Background: Surgery is not generally considered standard of care in preoperative pathological verified spread to N2 mediastinal lymph nodes in NSCLC. Methods: Previously untreated histologically verified NSCLC stages T1-3N2M0 were randomized to reg. A (Paclitaxel 225 mg/m2 + Carboplatin AUC6 day 1 q 3 wks for 3 courses, followed by surgery with ipsilateral mediastinal lymph node sampling followed by radiotherapy 2Gy x 30 fractions, 5F/W) or reg. B: same as A without surgery (sequential chemo-radiotherapy). 406 pts were needed to detect a 10% 5-year survival increase with 80% power and type 1-error of 5%. The study was approved by ethical committees. Pts gave informed consent. Results: 170 pts were randomized to A and 171 to B from 1998-2009 when study closed due to concomitant chemo-radiotherapy becoming standard instead of sequential treatment. Median age was 61 years (range 33-76 yrs), 59% were males, 43% had performance status 0. Stages T1N2M0, T2N2M0, and T3N2M0 occurred in 19%, 60%, and 21%, res...