NIPH Clinical Trials Search

UMIN ID: C000000110

Registered date:02/09/2005

Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedStage IIIb/IV NSCLC
Date of first enrollment2001/06/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients in group one will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carboplatin on day 1. Patients in group two will receive infusions of gemcitabine and vinorelbine on days 1 and 8. Treatment in all groups may be repeated every 3 weeks for up to six courses.


Primary Outcome1-year survival rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum74years-old
GenderMale and Female
Include criteria
Exclude criteriaPatients were excluded if they had any active concomitant malignancies, symptomatic brain metastases, prior radiotherapy to the sole site of measurable disease, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, liver cirrhosis, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Nobuyuki Yamamoto
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan Japan
Affiliation Shizuoka Cancer Center Thoracic Oncology