Phase II study of S-1 for non-small lung cancer after failure of two or three prior chemotherapy regimens
- Conditions
- on Small Cell Lung Cancer (NSCLC)
- Registration Number
- JPRN-UMIN000003986
- Lead Sponsor
- ational Hospital Organization Asahikawa Medical Cencer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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