NIPH Clinical Trials Search

UMIN ID: C000000135

Registered date:08/09/2005

A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-small cell lung cancer
Date of first enrollment2005/03/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The treatment schedule included carboplatin AUC 4 on day 1, and gemcitabine 1000 mg/ m2 on days 1 and 8, every 3 weeks. (Below six courses more than three courses.)


Primary OutcomeResponse Rate(according to RECIST criteria)
Secondary OutcomeMedian survival time, 1-year survival, Adverse events, Time to Progression, Quality of Life

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)After thoracic irradiation 2)A case having severe infection and a serious complication 3)Requiring treatment pleural/ascites /pericardial effusion, 4)Interstitial pneumonia or active lung fibrosis on chest X-ray, 5)Symptomatic brain metastases 6)Double cancer 7)Others

Related Information


public contact
Name Takashi Nishimura
Address 4-6,Minatojima-Nakamachi,Chuo-ku,Kobe 650-0046 Japan Japan
Telephone 078-302-4321
Affiliation Kobe City General Hospital Respiratory Medicine
scientific contact
Name Nobuyuki Katakami
Address 2-2,Minatojima-Minamimachi,Chuo-ku,Kobe 650-0047 Japan Japan
Telephone 078-304-5200
Affiliation Institute of Biomedical Research and Innovation Department of Translational Research Division of Integrated Oncology