Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group

UMIN ID: UMIN000001131

Registered date:01/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2004/09/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carboplatin on day 8.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Safety,survival,toxicity, QOL

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients were excluded if they had any active concomitant malignancies, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, 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: Niigata Lung Cancer Treatment Group
• Source(s) of Monetary Support: none