advanced or recurrent NSCLC
Conditions
Interventions
S-1 80mg/m2/day(administration on Mon,Wed,Fri,Sun) Carboplatin AUC5(every3weeks)
Sponsors
Tokushima university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven non small cell lung cancer. 2)advanced or recurrent NSCLC. 3)Patients with no prior chemotherapy. 4)Age of 20 years or older. 5)ECOG Performance status:0-1 6)Sufficient oral intake. 7)Have adequate organ function within two week before study entry. WBC>=4000/mm3 hemoglobin>=9.0g/dl Platelets>=100000/mm3 Total bilirubin>=1.5mg/dl Creatinine<=1.2mg/dl Creatinine clearance>=60ml/min AST,ALT<=100IU PaO2>=60torr or SpO2>=90% 8)Patients with expected life for at 3 months 9)Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with pleural or pericardial effusion ,or ascites. 2) Patients with active double cancer. 3)Patients with significant complications. 4)Patients with serious diarrhea. 5)Patients with active infection. 6)Patients with symptomatic brain metastasis. 7)Being treated with flucytosine, phenytoin,warfarin. 8)Uncontrolled psychiatric disease. 9) allergic more than and equal to grade3. 10)Patients with interstitial pneumonia or pulmonary fibrosis. 11)History of serious allergic reaction with S-1 or CBDCA. 12)Patients with pregnancy or lactation. 13)Patients with HIV,HBV 14)Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Response Rate Safety Quality of life | — |
Countries
Japan
Outcome results
None listed