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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive20 to 75OtherWJTOG0101
NCT00139971

Trial Description

Summary

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

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

West Japan Thoracic Oncology Group

Hirohito Tada, MDPrincipal Investigator

Hirohito Tada, MDPh: +81-6-6929-1221
  Email: htada@attglobal.net

Trial Sites

Japan
  Osaka
 Osaka City General Hospital
 Hirohito Tada, MD Ph: +81-6-6929-1221
  Email: htada@attglobal.net
 Hirohito Tada, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00139971
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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