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

This study has been completed.
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: December 8, 2013
Last verified: December 2011
  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:


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 ]

Enrollment: 432
Study Start Date: August 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 8, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014