NCT00765687

Brief Summary

A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
432

participants targeted

Target at P75+ for phase_4 nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2008

Typical duration for phase_4 nonsmall-cell-lung-cancer

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

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2011

Enrollment Period

3.8 years

First QC Date

September 29, 2008

Last Update Submit

December 8, 2013

Conditions

Non-small Cell Lung CancerBone Metastases

Outcome Measures

Primary Outcomes (1)

  • Skeleton-related event

    24 months

Secondary Outcomes (1)

  • overall survival

    24 months

Study Arms (1)

Observation

NO INTERVENTION
Drug: bisphosphates

Interventions

bisphosphatesDRUG

any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Observation

Eligibility Criteria

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

You may qualify if:

  • Age \>18, either sex
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray,CT or others)
  • Without receiving zoledronic acid
  • 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)

SunYat-senU

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zhang Li, Master

    Cancer Center of Sun Yat-Sen University (CCSU)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 3, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 10, 2013

Record last verified: 2011-12

Locations

CN(1)