Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

Phase 4

Completed

• Conditions: Non Small Cell Lung Cancer; Bone Metastases; High NTX Level
• Interventions: Drug: zometa

• Registration Number: NCT00762346
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2011-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-12-08
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• 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 Criteria

• 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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	zometa	-

Primary Outcome Measures

Name	Time	Method
Skeleton-related event	2 years

Secondary Outcome Measures

Name	Time	Method
OS	2 years

Trial Locations

Locations (1)

cancer center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China