NCT00319514

Brief Summary

To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

First QC Date

April 28, 2006

Last Update Submit

March 10, 2008

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

Secondary Outcomes (3)

  • Progression-free survival

  • Overall survival

  • Safety

Interventions

DocetaxelDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically or cytologically proven non-small cell lung cancer
  • no prior chemotherapy or only adjuvant chemotherapy which had been completed \>6 months before registration
  • ECOG performance status 0 to 2
  • measurable lesion(s)
  • normal marrow, hepatic and renal functions
  • provision of written informed consent

You may not qualify if:

  • active infection or severe comorbidities
  • history of anaphylaxis of any origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405 760, South Korea

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Se Hoon Park, MD

    Gachon University Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2006

First Posted

April 27, 2006

Study Start

April 1, 2004

Study Completion

October 1, 2006

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

KR(1)