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Random Trial for Elderly Patients With NSCLC

NCT ID: NCT00265694

Last Updated: 2005-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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. The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
3. Gemcitabine and carboplatin have favorable toxicity profile.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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vinorelbine, gemcitabine and carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Principal Investigators

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Young Jin Yuh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Inje University Sanggyepaik Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young Jin Yuh, M.D.

Role: CONTACT

Phone: 82-2-950-1460

Email: [email protected]

Facility Contacts

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Young Jin Yuh, M.D.

Role: primary

Other Identifiers

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INJE05-06

Identifier Type: -

Identifier Source: org_study_id