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

Primary Purpose

Non-small Cell Lung Cancer, Bone Metastases

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
bisphosphates
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • SunYat-senU

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Observation

Arm Description

Outcomes

Primary Outcome Measures

Skeleton-related event

Secondary Outcome Measures

overall survival

Full Information

First Posted
September 29, 2008
Last Updated
December 8, 2013
Sponsor
Sun Yat-sen University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00765687
Brief Title
Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates
Acronym
BLEST
Official Title
A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Bone Metastases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
bisphosphates
Intervention Description
any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
Primary Outcome Measure Information:
Title
Skeleton-related event
Time Frame
24 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Li, Master
Organizational Affiliation
Cancer Center of Sun Yat-Sen University (CCSU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
SunYat-senU
City
GuangZhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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