NCT00762346

Brief Summary

A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2011

Enrollment Period

4.5 years

First QC Date

September 29, 2008

Last Update Submit

December 8, 2013

Conditions

Non Small Cell Lung CancerBone MetastasesHigh NTX Level

Keywords

non small cell lung cancerNTXzometa

Outcome Measures

Primary Outcomes (1)

  • Skeleton-related event

    2 years

Secondary Outcomes (1)

  • OS

    2 years

Study Arms (1)

1

EXPERIMENTAL
Drug: zometa

Interventions

zometaDRUG

zometa 4mg i.v. every 4 weeks for up to 2 years

1

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray, CT or others)
  • NTX \> 50nM BCE/mM creatinine
  • Life expectancy \> 6 M
  • ECOG \<= 2
  • Signed ICF

You may not qualify if:

  • Women who are pregnant or in lactation
  • Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  • Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  • Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cancer center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Li Zhang, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profressor

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 10, 2013

Record last verified: 2011-12

Locations

CN(1)