Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2007
INTERVENTION: CDDP: 80mg/m2 day1 Docetaxel: 60mg/m2 day1 q3‐4weeks Doc(60mg/m2) day8 TS��1(800mg/m2) day1‐21 q4‐5weeks CONDITION: Stage IIIB/IV or ppstoperative recurrent non‐small sell lung cancer PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: PFS; TTF; Response rate; Adverse event; QOL INCLUSION CRITERIA: 1.Histologically or cytologically confirmed NSCLC 2.Oral intake is possible 3.Stage IIIB or IV and recurrence after operation 4.With measurable or assessable legion(s) 5.Age of 20 to 74‐year old 6.PS(ECOG)0 or 1 7.Without prior anti‐tumor therapy 8.Preserved organ functions 8.Adequate bone marrow,hepatic and renal function 9.Written IC 10.Life expectancy longer than 12 weeks
Epistemonikos ID: d8e949cbfc1207cd7c2fce7286145f0344d0cc5d
First added on: Aug 21, 2024