Vinorelbine-carboplatin for patients with stage IIIB, IV non-small cell lung cancer:a phase II study of the Niigata Lung Cancer Treatment Group

UMIN ID: UMIN000001134

Registered date:28/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2003/11/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): VNR 25mg/m2 day1,8 CBDCA AUC=5 day1

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Overall survival,safety, toxicity, QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Patients were excluded if they had any active concomitant malignancies,infections, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction, 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