NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000116

Registered date:06/09/2005

randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedstage IB-IIIA non small cell lung cancer after complete resection
Date of first enrollment2001/06/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 cycle standard arm: UFT 250mg/m2, daily for 1 year

Outcome(s)

Primary Outcomeoverall survival
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1.completely resected non small cell lung cancer 2.no prior anti cancer treatment for thoracic malignancy exept for this operation 3.pathological stage IB, II, and stage IIIA with only one station of n2 disease 4.PS 0-1 5.age 20-75 6.adequate oragan function for chemotherapy 7.written informed consent
Exclude criteria1.small cell lung cancer or low grade malignancy of lung cancer 2.incomplete resection 3.apparant interstitial pneumonitis at chest rentogenogram 4.inadequate conditon for chemotherapy

Related Information

Contact

public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
E-mail datacenter@wjog.jp
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Hirohito Tada, MD.
Address Miyakojima Hondhori 2-13-22 Japan
Telephone
E-mail
Affiliation Osaka City General Hospital Division of Thoracic Surgery