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

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.

Study Overview

• Status: Completed
• Conditions: Bone Metastases; Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: bisphosphates

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China
      • SunYat-senU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skeleton-related event	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	24 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Novartis
• Investigators: Principal Investigator: Zhang Li, Master, Cancer Center of Sun Yat-Sen University (CCSU)

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 8, 2013
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Bone Diseases; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: CZOL446ECN07