Vinorelbine-zoledronate for NSCLC patients with bone metastasis:a phase II study of the Niigata Lung Cancer Treatment Group

UMIN ID: UMIN000002380

Registered date:25/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2010/08/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Vinorelbin 25mg/m2 day 1,8 zoledronate 4mg day1 every 3 weeks

Outcome(s)

• Primary Outcome: SRE: Skeletal Related Events
• Secondary Outcome: Time to SRE, toxicity, response rate, PFS, OS, pain score, and QOL

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1 active concomitant malignancies,infections 2 symptomatic brain metastases 3 past history of severe allergic reactions to drugs 4 interstitial pneumonia identified by chest X-ray 5 bone metastasis or hypercalcemia required immediate treatment 6 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