Phase3 study of docetaxel/TS-1 versus docetaxel in patients with previously treated non-small cell lung cancer
- Conditions
- on-small cell lung cancer patients with postoperative recurrence or stage3-4 with chemotherapy treatment history
- Registration Number
- JPRN-UMIN000011391
- Lead Sponsor
- Kanto respiratory disease study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 260
Not provided
1)Patients with severe infection is suspected or there is fever cases are complicated by severe infection 2)Cases where there is intention or possibility pregnant women, pregnancy and breast-feeding 3)Patients having double cancer of activity of simultaneity, and multiple cancer or metachronous 4)Patients with severe drug allergy 5)Cases of bleeding (hemorrhagic enteritis, ischemic colitis, necrotizing enterocolitis) and gastrointestinal ulceration 6)Cases is determined pulmonary fibrosis or interstitial pneumonia is a problem in clinical CT images from 7)Cases are complicated by lung disease emphysema of advanced, chronic bronchitis severe, such as bronchial asthma 8)Cases with pleural effusion in need of treatment of drainage, etc., and storage of pericardial effusion 9)Brain metastasis of symptomatic 10)Patients with a myocardial infarction within 3 months after onset (diabetes that is difficult to control, liver damage (cirrhosis), renal failure, angina, and arrhythmia) and serious complication 119Patients with a history of administration TS-1 or DTX before treatment 12)Case it is determined to be inappropriate other attending physician to safely performed this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method