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

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ClinicalTrials.gov Identifier: NCT00765687
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : December 10, 2013
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

September 29, 2008
October 3, 2008
December 10, 2013
August 2008
May 2012   (Final data collection date for primary outcome measure)
Skeleton-related event [ Time Frame: 24 months ]
Skeleton-related event
Complete list of historical versions of study NCT00765687 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 24 months ]
overall survival
Not Provided
Not Provided
 
Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates
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
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Non-small Cell Lung Cancer
  • Bone Metastases
Drug: 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
No Intervention: Observation
Intervention: Drug: bisphosphates
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
432
1200
May 2012
May 2012   (Final data collection date for primary outcome measure)

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 -
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00765687
CZOL446ECN07
Yes
Not Provided
Not Provided
Li Zhang, Sun Yat-sen University
Sun Yat-sen University
Novartis
Principal Investigator: Zhang Li, Master Cancer Center of Sun Yat-Sen University (CCSU)
Sun Yat-sen University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP