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

Phase 3

• Conditions: Lung Cancer
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT02622607
• Lead Sponsor: Tang-Du Hospital

Brief 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 .

Detailed Description

Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. which can lead to pain, decreased mobility and skeletal complications .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 SREs from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid 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 .

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZOL	Zoledronic acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Bone Metastases at 12 Months	Months 12	Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	Up to 24 months	Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Percentage of Participants With Overall Survival	Months 6, 12, 18, and 24 ]

Trial Locations

Locations (1)

Department of Oncology，Tangdu Hospital，Fourth Millitary Medical University; 🇨🇳 XI'an, Shaanxi, China