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

NCT ID: NCT00765687

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Observation

Group Type NO_INTERVENTION

bisphosphates

Intervention Type DRUG

any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Interventions

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bisphosphates

any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Profressor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhang Li, Master

Role: PRINCIPAL_INVESTIGATOR

Cancer Center of Sun Yat-Sen University (CCSU)

Locations

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SunYat-senU

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CZOL446ECN07

Identifier Type: -

Identifier Source: org_study_id