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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622607
• Other study ID #: ZOL
• Status: Recruiting
• Phase: Phase 3
• First received: November 30, 2015
• Last updated: July 19, 2017
• Start date: January 2013
• Est. completion date: March 2018

Study information

• Verified date: July 2017
• Source: Tang-Du Hospital
• Contact: He-Long Zhang, M.D.
• Phone: 13519128910
• Email: zhanghelong[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Zoledronic acid
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride)

Locations

Country	Name	City	State
China	Department of Oncology,Tangdu Hospital,Fourth Millitary Medical University	XI'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Bone Metastases at 12 Months	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).	Months 12
Secondary	Progression-Free Survival	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.	Up to 24 months
Secondary	Percentage of Participants With Overall Survival		Months 6, 12, 18, and 24 ]