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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Bone Metastases

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Trial Information

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


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 -

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Skeleton-related event

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Zhang Li, Master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center of Sun Yat-Sen University (CCSU)

Authority:

China: Food and Drug Administration

Study ID:

CZOL446ECN07

NCT ID:

NCT00765687

Start Date:

August 2008

Completion Date:

May 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Bone Metastases
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

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