RCT PhaseII trial of Paclitaxel (P) and Carboplatin (C) plus continuous Gemcitabine (G) versus Gemcitabine (G) and Carboplatin (C) plus continuous Gemcitabine in untreated non-small cell lung cancer (NSCLC)

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: Three cycles of Pacritaxel+ Carboplatin followed by maintenance Gemcitabine in 21‐day cycles until progression disease Three cycles of Gemcitabine+Carboplatin followed by maintenance Gemcitabine in 21‐day cycles until progression disease CONDITION: Non‐small cell lung cancer PRIMARY OUTCOME: Progression Free Survival: PFS INCLUSION CRITERIA: 1) Histologically or cytologically confirmed non‐small‐cell lung cancer with Chemo‐naive patients 2) Ptients who have measurable lesion or evaluable lesion by RECIST 3) Stage three/four without any indications for radiotherapy 4) Patients aged from 20 to 75years older 5)ECOG PS 0‐1 6) Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 4,000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 10 g/dL AST/ALT <=100IU/L T.Bil <= 1.5 g/dL Ccr >=60mL/min, sCr: x 1.2 of upper limit of normal or less. SpO2 >= 95% as room air 7)Patients are excepted to live over 3 months after administration day. 8)Written informed consent from the patients
Epistemonikos ID: dad2645fa55ddc780bc578437507ddfa04f7ca2c
First added on: Aug 22, 2024