NCT02622607

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3 lung-cancer

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

5.2 years

First QC Date

November 30, 2015

Last Update Submit

July 19, 2017

Conditions

Lung Cancer

Keywords

ZOLPreventionlung cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Progression-Free Survival

    Up to 24 months

  • Percentage of Participants With Overall Survival

    Months 6, 12, 18, and 24 ]

Study Arms (2)

ZOL

EXPERIMENTAL

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

Drug: Zoledronic acid

Control

NO INTERVENTION

No investigational treatment

Interventions

Zoledronic acidDRUG

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

Also known as: Zometa
ZOL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years of age, male or female
  • histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis
  • no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy
  • life expectancy of ≥6 months
  • adequate renal, hematologic, and hepatic
  • Eastern Cooperative Oncology Group(ECOG) performance status≤2
  • All patients provided written informed consent

You may not qualify if:

  • Treatment with other bisphosphonates
  • Presence of brain metastases
  • Be allergic to ZOL
  • attending other unlisted drug clinical trials,currently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology，Tangdu Hospital，Fourth Millitary Medical University

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • He-Long Zhang, M.D.

    Department of Oncology，Tangdu Hospital

    STUDY CHAIR

Central Study Contacts

He-Long Zhang, M.D.

CONTACT

13519128910zhanghelong@medmail.com.cn

Mi Jiao, M.M.

CONTACT

18392467550mimi10903@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 4, 2015

Study Start

January 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

CN(1)