Non Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are fol
Sponsors
National Hospital Organization Asahikawa Medical Cencer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically and/or cytologically proven non-small cell carcinoma. 2.Prior chemotherapy with more than two regimens, necessarily including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion. 3.The presence of measurable disease. 4.An ECOG performance status ranging from 0 to 2. 5.Aged greater than 20 year-old. 6.Major organs are in normal conditions. White blood cell count => 3000/mm3 Absolute granulocyte count => 1500/mm3 Hemoglobin => 9.0g/dL Platelet count => 100,000/mm3 Serum bilirubin <= 1.8 mg/dL or 1.5 times upper limit of normal AST, ALT <= 2 times upper limit of normal Serum creatinine <= 1.5 mg/dL Oxyhemoglobin satulation (SpO2) => 90% 7.Life expectancy should exceed at least 3 months. 8.All participants have given written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous histories of drug allergy, which may increase the risk of this study. 2. Serious concomitant infection or high-grade fever exceeding 38 deg C or more. 3. Usages of oral steroids or immunosuppressive drugs. 4. Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes. 5. Interstitial pneumonia or pulmonary fibrosis on chest X-ray or CT scans. 6. Any prior treatments with S-1 or UFT. 7. Any coelomic fluids (pleural, pericardial, or ascites), which require emergent treatment. 8. Symptomatic brain metastases. 9. Other active multiple cancers. 10. Severe heart diseases. 11. Psychiatric conditions, which may increase the risks associated with the study participation. 12. Pregnant or nursing women. 13. Other conditions, on which the judgment of the investigator would make the patient inappropriate for entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate by CT scan and physical exam at the end of every even course or every 4 weeks until progressive disease (PD) or initiation of new anticancer therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival every 2 months after PD for up to 12 months following the end of patient accrual Duration of response by CT scan and physical exam at the end of every even course or every 4 weeks until PD or initiation of new anticancer therapy Progression-free survival by CT scan and physical exam every 4 weeks Safety by laboratory evaluations and assessment of adverse events on days 1, 8, and 15 of every course, EOS, periodically, and 30 days after treatment | — |
Countries
Japan
Contacts
Public ContactYutaka Nishigaki
National Hospital Organization Asahikawa Medical Center Department of Clinical Research
Outcome results
None listed