Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates

Phase 4

Completed

• Conditions: Non-small Cell Lung Cancer; Bone Metastases
• Interventions: Drug: bisphosphates

• Registration Number: NCT00765687
• Lead Sponsor: Sun Yat-sen University

Brief Summary

A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Status Verified: 2011-12
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2013-12-08
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. Age >18, either sex
2. Histologically confirmed non-small cell cancer
3. One bone metastasis at least confirmed by image(X ray,CT or others)
4. Without receiving zoledronic acid
5. Life expectancy > 6 M
6. ECOG <= 2
7. Signed ICF

Exclusion Criteria

1. Women who are pregnant or in lactation
2. Patients with hyperostosis
3. with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
4. Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
5. 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
Observation	bisphosphates	-

Primary Outcome Measures

Name	Time	Method
Skeleton-related event	24 months

Secondary Outcome Measures

Name	Time	Method
overall survival	24 months

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 GuangZhou, Guangdong, China