NCT01737216

Brief Summary

Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.

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
100

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Nov 2012

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

November 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 31, 2012

Status Verified

November 1, 2012

Enrollment Period

3.2 years

First QC Date

November 27, 2012

Last Update Submit

December 28, 2012

Conditions

Lung Cancer

Keywords

Agedpatients

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival(PFS)

    1 year

Secondary Outcomes (3)

  • Overall survival(OS)

    3 years

  • Bone mineral density(BMD)

    1 year

  • Quality of life(QOL)

    1 year

Study Arms (2)

Zoledronic acid plus First-line chemotherapy

EXPERIMENTAL
Drug: Zoledronic acid plus EP/TP

First-line chemotherapy

ACTIVE COMPARATOR
Drug: EP/TP

Interventions

Zoledronic acid plus EP/TPDRUG

Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression

Zoledronic acid plus First-line chemotherapy
EP/TPDRUG

Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles

Also known as: First-line chemotherapy
First-line chemotherapy

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Signed informed consent form
  • Age ≥70 years
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  • Histologically or cytologically confirmed lung cancer
  • Did not receive bisphosphonate treatment

You may not qualify if:

  • Appear relapse and metastasis
  • receive other bisphosphonate treatment
  • Active or uncontrolled infection
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Tumor Hospital

Shijiazhuang, Hebei, 050011, China

Location

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

  • Wei Liu

    Hebei Tumor Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

December 31, 2012

Record last verified: 2012-11

Locations

CN(1)