NCT00265694

Brief Summary

  1. 1.Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy.
  2. 2.The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
  3. 3.Gemcitabine and carboplatin have favorable toxicity profile.

Trial Health

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Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
Last Updated

December 15, 2005

Status Verified

June 1, 2005

First QC Date

December 14, 2005

Last Update Submit

December 14, 2005

Conditions

Non-Small Cell Lung Cancer

Interventions

vinorelbine, gemcitabine and carboplatinDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC
  • No previous chemotherapy history
  • Age ≥ 65 years
  • ECOG performance status ≤ 2
  • Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin \< 2.0 mg/dL, AST/ALT levels \< 3 × the upper limit of normal, serum creatinine \< 2.0 mg/dL)
  • Patients with informed written consent

You may not qualify if:

  • Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Sanggyepaik Hospital

Seoul, 139-707, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

VinorelbineGemcitabineCarboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Young Jin Yuh, M.D.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Jin Yuh, M.D.

CONTACT

82-2-950-1460yjyuh@sanggyepaik.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Last Updated

December 15, 2005

Record last verified: 2005-06

Locations

KR(1)