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

UMIN ID: C000000110

Registered date:02/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage IIIb/IV NSCLC
• Date of first enrollment: 2001/06/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: 1-year survival rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 74years-old
• Gender: Male and Female
• Exclude criteria: Patients 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

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None