patients >
Conditions
Interventions
S-1 (40-60 mg/body twice per day) on days 1 to 14 of a 21-day cycle until progressive disease.
Sponsors
Shinshu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological or cytological proven non-small cell lung cancer 2) Locally advanced, metastatic or recurrent non-small cell lung cancer (clinical stage 3A, 3B or 4, according to TNM classification ver 7 for which curative radiotherapy is not indicated. 3) With measurable lesions by RECIST. 4) No prior chemotherapy except EGFR-TKI. Patients who experienced recurrence more than 180 days after completion of postoperative adjuvant chemotherapy with tegafur-uracil capsules/granules (UFT) will be eligible 5) Age of 80 years or older 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7) Life expectancy is more than 12 weeks 8) Adequate organ function shown in physical examinations within 7 days before the registration, as defined below: Neutrophil =>1500/mm3 Platelet count =>100000/mm3 Hemoglobin =>9.0g/dL AST ALT <= 3 x ULN Total bilirubin <=1.5mg/dL Creatinine <=1.5mg/dL Creatinine clearance =>40mL/min SpO2 =>90% 9) Ability to take drugs orally 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of severe hypersensitivity drug reaction 2) Prior radiotherapy to the primary tumor except the radiotherapy to the bone metastasis and the brain metastasis. 3) Patients with administration contraindication to S-1 4) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval except carcinoma in situ of the cervix and basal type skin cancer 5) Concomitant active infection 6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 7) Severe complication(s), e.g., renal failure, hepatic failure, poorly controlled diabetes, or poorly controlled hypertension 8) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina) 9) Patients with severe diarrhea 10) Pleural and peritoneal likely to require surgical intervention 11) Symptomatic brain metastasis. 12) Concomitant treatment with flucytosine, phenytoin or warfarin 13) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression free survival 1 year survival rate Response rate Time to treatment failure Safety Quality of life | — |
Countries
Japan
Outcome results
None listed