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