Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer

NCT ID: NCT00139971

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Brief Summary

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To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.

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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gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6

Intervention Type DRUG

UFT 250mg/m2, daily for 1 year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. completely resected non small cell lung cancer
2. no prior anti cancer treatment for thoracic malignancy exept for this operation
3. pathological stage IB, II, and stage IIIA with only one station of n2 disease
4. PS 0-1
5. age 20-75
6. adequate organ function for chemotherapy
7. written informed consent

Exclusion Criteria

1. small cell lung cancer or low grade malignancy of lung cancer
2. incomplete resection
3. apparent interstitial pneumonitis at chest rentogenogram
4. inadequate condition for chemotherapy
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 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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Hirohito Tada, MD

Role: PRINCIPAL_INVESTIGATOR

West Japan Thoracic Oncology Group

Locations

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Osaka City General Hospital

Osaka, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hirohito Tada, MD

Role: CONTACT

+81-6-6929-1221

Facility Contacts

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Hirohito Tada, MD

Role: primary

+81-6-6929-1221

Related Links

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Other Identifiers

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WJTOG0101

Identifier Type: -

Identifier Source: org_study_id