Randomized phase II study of induction chemotherapy with gemcitabine plus cisplatin followed by sequential radiotherapy versus radiotherapy alone in patients with stage III non-small cell lung cancer.

Purpose: This randomized phase II trial was conducted to compare the overall response rate (ORR) of gemcitabine plus cisplatin combination followed by sequential radiotherapy (RT) (arm A) versus RT alone (arm B) in chemonaive patients with stage IIIA or IIIB non-small cell lung cancer (NSCLC). Secondary objectives were to evaluate time to progressive disease (TTPD), overall survival, and treatment tolerability in both arms.

Patients And Methods: Eligible patients were required to have stage IIIA or stage IIIB NSCLC, no previous chemotherapy, ECOG performance status of 0-2, bidimensionally measurable disease, and age 18 to 75 years.