NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000547

Registered date:01/01/2007

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNon small cell lung cancer
Date of first enrollment2006/07/01
Target sample size76
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeDose reduction rate (DRR) in the second cycle
Secondary OutcomeDeferment 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1)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

Contact

public contact
Name Tadashi Mio
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto City Japan
Telephone 075-751-3830
E-mail mio@kuhp.kyoto-u.ac.jp
Affiliation Kyoto University Respiratory Medicine
scientific contact
Name Kouichi Nakatani
Address 1-1Mukaihata, Fushimi-ku, Kyoto City, Japan Japan
Telephone 075-643-4325
E-mail
Affiliation National Hospital Organization Kyoto Medical Center Pulmonary Medicine