Screening Non Small Cell Lung Cancer With Bone Metastasis... | NCT00765687

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

NCT00765687

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Dec 10, 2013Estimated

Enrollment

432Actual

Phase

Phase 4

Conditions

Non-small Cell Lung Cancer
Bone Metastases

Interventions

bisphosphates

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Sep 29, 2008

First Submission Date that Met QC Criteria

Oct 2, 2008

First Posted Date

Oct 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2013

Last Update Posted Date

Dec 10, 2013Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

432Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation	No Intervention		Drug: bisphosphates

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bisphosphates	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	Observation

Measure	Description	Time Frame
Skeleton-related event		24 months

Measure	Description	Time Frame
overall survival		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18, either sex
Histologically confirmed non-small cell cancer
One bone metastasis at least confirmed by image(X ray,CT or others)
Without receiving zoledronic acid
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 -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhang Li, Master	Cancer Center of Sun Yat-Sen University (CCSU)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SunYat-senU		Guangzhou	Guangdong		China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided