NIPH Clinical Trials Search

UMIN ID: UMIN000001658

Registered date:26/01/2009

A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon Small Cell Lung Cancer
Date of first enrollment2007/09/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)TS-1 CDDP,TS-1


Primary OutcomeRelapse-free survival of 2 years, to searches for the chemotherapy effect prediction factor.
Secondary OutcomeOverall survival (OS), Rate of adverse events, Relative dose intensity, to searches for a prognosis prediction factor.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) clinically significant drug allergy 2) Under treatment with flucytosine, phenytoin, Warfarin Potassium, other trial drugs. 3) The infection which needs the medical treatment by antibiotics, and other serious complications 4) The case which has diarrhea continuously 5) The case which has clear interstitial pneumonia or a clear fibroid lung with a chest simple X ray 6) The case which has malignant tumors other than the lung cancer 7) The case which has the past of a malignant tumor 8) Not suitable for participating in the study for any other reason

Related Information


public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Yasuo Iwamoto
Address 7-33.Moto-machi. Naka-ku. Hiroshima.shi.730-8518 Japan Japan
Telephone 082-221-2291
Affiliation Hiroshima city hospital Dept of chemotherapy center