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A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer

NCT ID: NCT00144053

Last Updated: 2006-01-06

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC.

Detailed Description

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Conditions

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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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Cisplatin+Vindesine+MMC/ concurrent radiation

Intervention Type DRUG

Irinotecan+Carboplatin/concurrent radiation

Intervention Type DRUG

Paclitaxel+Carboplatin/concurrent radiation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All patients had histologically or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Japan Thoracic Oncology Group

OTHER

Sponsor Role lead

Principal Investigators

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Hisao Uejima, MD

Role: PRINCIPAL_INVESTIGATOR

West Japan Thoracic Oncology Group

Related Links

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http://www.wjtog.org/

Related Info

Other Identifiers

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WJTOG0105

Identifier Type: -

Identifier Source: org_study_id