Advanced non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)Stage IIIB with no induction of radiation therapy, and Stage IV 3)Age range from 20 to 74 years 4)ECOG performance status of 0 or 1 5)a life expectancy of 12 weeks or more 6)Measurable by RECST criteria 7)no previous chemotherapy or radiotherapy 8)adequate bone marrow, liver, and renal functions WBC > 4000 mm-3 Neutro > 2000 mm-3 Platlets > 100000 mm-3 Hb > 9 g dL-1 T-Bil< 1.5 mg dL-1 AST, ALT<100IU/L s-Cr < 1.5 mg dL-1 CCr > 60 mL min-1 PaO2>70torr 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Pulmonary fibrosis detectable on chest X-ray films 2)Massive pleural effusion, ascites and pericardial effusion required drainage 3)Concomitant malignancy 4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome 5)Symptomatic brain metastasis 6)Pregnant or milk-feeding female. Intention to be pregnant in the future 7)With severe allergy 8)Other clinical difficulties to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess toxicity, overall survival and progression-free survival | — |
Countries
Japan
Contacts
Gunma University Hospital Department of Respiratory Medicine