A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000000896
- Lead Sponsor
- Thoracic Oncology Research Group
- Brief Summary
Treatment was administered for median 4 courses (range 1 - 13) over a median 125-day period in 34 patients The overall response rate was 23.5% (no complete response and 8 partial response; 95% confidence interval: 9.1 - 38.0%). The median progression-free and overall survival times were 6.6 and 19.9 months, respectively. The 1- and 2-year survival rates were 58.8 and 30.9%, respectively. Toxicity was mild during the entire treatment period, except for 3 grade 3 interstitial pneumonia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Not provided
1) Any contraindication for S-1 or gemcitabine. 2) Active concomitant malignancy. 3) Active infectious diseases. 4) Prior resection of primary tumor. 5) Interstitial pneumonia obviously presented by x-ray and/or clinical manifestations. 6) Experience of any pulmonary event during the previous chemotherapy. 7) Prior chemotherapy including any primidine analogue such as 5-FU, tegafur, UFT, S-1, capecitabine, gemcitabine and Ara-C. 8) Brain metastasis with symptoms or requirement of treatment. 9) Requirement of thoracic irradiation. 10) Pleural effusion, ascites or pericardial effusion requiring treatment. 11) Serious abnormalty in ECG. 12) Uncontrolled diabetes mellitus. 13) Women in regnancy, potential pregnancy, or breast feeding. Men willing to cause pregnancy. 14) Other inadequate conditions .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method Toxicity, Overall survival, Progression free survival, Subset analyses