Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC).
- Conditions
- on small cell lung cancer
- Registration Number
- JPRN-UMIN000000547
- Lead Sponsor
- Kyoto Thoracic Oncology Research Group (KTORG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 76
Not provided
1)Clinically apparent interstitial pneumonia in chest X ray or CT 2)Pleural or pericardial effusion, or ascites requiring treatment 3)Treated Pericardial effusion or ascites 4)SVC syndrome 5)Brain metastasis requiring treatment 6)Patients with active concomitant cancer 7)Uncontrolled diabetes 8)Severe cardiovascular diseases a.uncontrollable hypertension b.congestive heart failure c.unstable angina, myocardial infarction or PTCA/CAGB therapy within the past six months d.uncontrollable arrythmias 9) Patients with liver cirrhosis 10) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11) Medical history of serious allergic reactions to any drug 12)Active inflammatory diseases 13)Active or chronic infectious diseases (especially patients with positive HBs-Ag or active mycobacterial infection) 14) Regular use of steroids or immunosupressive drugs 15)Refusal to blood transfusion 16)Patient with known bleeding disorders 17) Inappropriate patients for this study judged by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose reduction rate (DRR) in the second cycle
- Secondary Outcome Measures
Name Time Method Deferment rate (DR) of the second cycle Objective Response Rate (ORR) Time to progression (TTP) Overall survival (OS) Safety (Toxicity profile) Platelet transfusion rate (PER)