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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by West Japan Thoracic Oncology Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139971
First Posted: August 31, 2005
Last Update Posted: January 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
West Japan Thoracic Oncology Group
  Purpose
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.

Condition Intervention Phase
Lung Cancer Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 Drug: UFT 250mg/m2, daily for 1 year Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by West Japan Thoracic Oncology Group:

Primary Outcome Measures:
  • 5 year survival rate

Secondary Outcome Measures:
  • Disease free survival

Estimated Enrollment: 600
Study Start Date: December 2001
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139971


Contacts
Contact: Hirohito Tada, MD +81-6-6929-1221 htada@attglobal.net

Locations
Japan
Osaka City General Hospital Recruiting
Osaka, Japan, 531-0021
Contact: Hirohito Tada, MD    +81-6-6929-1221    htada@attglobal.net   
Principal Investigator: Hirohito Tada, MD         
Sponsors and Collaborators
West Japan Thoracic Oncology Group
Investigators
Principal Investigator: Hirohito Tada, MD West Japan Thoracic Oncology Group
  More Information

ClinicalTrials.gov Identifier: NCT00139971     History of Changes
Other Study ID Numbers: WJTOG0101
First Submitted: August 30, 2005
First Posted: August 31, 2005
Last Update Posted: January 6, 2006
Last Verified: August 2005

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases