Overview

Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer

Status:
Unknown status
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
Summary
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of skeletal-related events(SREs）from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid（ZOL) in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tang-Du Hospital
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
Inclusion Criteria:

1. Age between 18 and 70 years of age, male or female

2. histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis

3. no evidence of bone metastatic lesions was radiographically confirmed by bone
scintigraphy

4. life expectancy of ≥6 months

5. adequate renal, hematologic, and hepatic

6. Eastern Cooperative Oncology Group(ECOG) performance status≤2

7. All patients provided written informed consent

Exclusion Criteria:

1. Treatment with other bisphosphonates

2. Presence of brain metastases

3. Be allergic to ZOL

4. attending other unlisted drug clinical trials,currently.