Status:
COMPLETED
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Novartis
Conditions:
Non Small Cell Lung Cancer
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.
Eligibility Criteria
Inclusion
- Age \> 18
- Histologically confirmed non-small cell cancer
- One bone metastasis at least confirmed by image(X ray, CT or others)
- NTX \> 50nM BCE/mM creatinine
- Life expectancy \> 6 M
- ECOG \<= 2
- Signed ICF
Exclusion
- Women who are pregnant or in lactation
- Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00762346
Start Date
September 1 2008
End Date
March 1 2013
Last Update
December 10 2013
Active Locations (1)
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1
cancer center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080