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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00765687
First received: September 29, 2008
Last updated: February 3, 2012
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Bone Metastases
 Drug: bisphosphates
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Skeleton-related event [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: August 2008
Estimated Study Completion Date: May 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765687

Locations
China, Guangdong
SunYat-senU
GuangZhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Novartis
Investigators
Principal Investigator: Zhang Li, Master Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

No publications provided

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00765687     History of Changes
Other Study ID Numbers: CZOL446ECN07
Study First Received: September 29, 2008
Last Updated: February 3, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013