Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC).

UMIN ID: UMIN000000547

Registered date:01/01/2007

Basic Information

• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 2006/07/01
• Target sample size: 76
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Gemcitabine(GEM):1000mg/m2 Day1,8 Carboplatin(CBDCA):AUC=4.5 Day1
Gemcitabine(GEM):1000mg/m2,Day1,8 Carboplatin(CBDCA):AUC=4.5,Day1 Dexamethasone(Dex) :8mg/body/day,Day-4.-3.-2.-1.0

Outcome(s)

• Primary Outcome: Dose reduction rate (DRR) in the second cycle
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Kyoto Thoracic Oncology Research Group (KTORG)
• Source(s) of Monetary Support: none