Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC)

INTERVENTION: Gemcitabine(GEM):1000mg/m2 Day1,8 Carboplatin(CBDCA):AUC=4.5 Day1 Gemcitabine(GEM):1000mg/m2,Day1,8 Carboplatin(CBDCA):AUC=4.5,Day1 Dexamethasone(Dex) :8mg/body/day,Day‐4.‐3.‐2.‐1.0 CONDITION: Non small cell lung cancer PRIMARY OUTCOME: Dose reduction rate (DRR) in the second cycle SECONDARY OUTCOME: Deferment rate (DR) of the second cycle; Objective Response Rate (ORR); Time to progression (TTP); Overall survival (OS); Safety (Toxicity profile); Platelet transfusion rate (PER) INCLUSION CRITERIA: 1) Pathological confirmed Stage IIIB IV NSCLC without previous chemotherapy 2) Measurable lesions (RECIST) 3) Age: >=20 and <80 4) no indication for radiation therapy 5) ECOG Performance Status: 0 ‐ 1 6) Sufficient organ functions defined as: neutrophil >1500/mm3 Platelet 1000000/mm3 Hemoglobin >9.0gr/dl AST/ALT : <2.5XULN of the instituion serum T‐bilirubin level<=1.5 mg/dl serum creatinine level<=1.5 mg/dl SpO2 >=95% (room air) 7) Expected survival over 3 months 8) Provided written informed consent