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

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ClinicalTrials.gov Identifier: NCT02622607
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Tracking Information
First Submitted Date  ICMJE November 30, 2015
First Posted Date  ICMJE December 4, 2015
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
Percentage of Participants With Bone Metastases at 12 Months [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02622607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
  • Progression-Free Survival [ Time Frame: 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 [ Time Frame: Months 6, 12, 18, and 24 ] ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer
Official Title  ICMJE Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Zoledronic acid
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride)
Other Name: Zometa
Study Arms  ICMJE
  • Experimental: ZOL
    Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months.
    Intervention: Drug: Zoledronic acid
  • No Intervention: Control
    No investigational treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: He-Long Zhang, M.D. 13519128910 zhanghelong@medmail.com.cn
Contact: Mi Jiao, M.M. 18392467550 mimi10903@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02622607
Other Study ID Numbers  ICMJE ZOL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tang-Du Hospital
Study Sponsor  ICMJE Tang-Du Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: He-Long Zhang, M.D. Department of Oncology,Tangdu Hospital
PRS Account Tang-Du Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP