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).
Phase 3
- Conditions
- on-small cell carcinoma
- Registration Number
- JPRN-UMIN000001916
- Lead Sponsor
- Thoracic Oncology Research Group (TORG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first SRE(Skeletal Related Events)
- Secondary Outcome Measures
Name Time Method SRE rate Adverse events Overall survival Progression free survival Treatment completion proportion Response rate Bone markers Pain score