Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).

UMIN ID: UMIN000001916

Registered date:01/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell carcinoma
• Date of first enrollment: 2008/10/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

platinum based combination chemotherapy with Zoledronic acid
platinum based combination chemotherapy

Outcome(s)

• Primary Outcome: Time to first SRE(Skeletal Related Events)
• Secondary Outcome: SRE rate Adverse events Overall survival Progression free survival Treatment completion proportion Response rate Bone markers Pain score

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Sever allergy 2. Required radiation or operation for bone metastases 3. Hypercalcemia 4. History of using bisphosphonate 5. Massive pleural effusion, ascites and pericardial effusion required drainage 6. Symptomatic brain metastasis 7. Patients with serious infections or suspected infections 8. Patients who need dental treatment 9. Active ineterstitial pneumonitis 10. Active concomitant malignancy 11. Pregnant or lactating women 12. Acute Myocardial Infarction within 6 months. 13. Patinets with uncontroled complications 14. Psychological symptoms not suitable for this study 15. other conditions not suitable for this study

Related Information

• Primary Sponsor: Thoracic Oncology Research Group (TORG)
• Source(s) of Monetary Support: None