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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 because the information has not been verified recently.
Verified August 2005 by West Japan Thoracic Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:
NCT00139971
First received: August 30, 2005
Last updated: January 5, 2006
Last verified: August 2005

August 30, 2005
January 5, 2006
December 2001
Not Provided
5 year survival rate
Same as current
Complete list of historical versions of study NCT00139971 on ClinicalTrials.gov Archive Site
Disease free survival
Same as current
Not Provided
Not Provided
 
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
Not Provided

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
  • Drug: UFT 250mg/m2, daily for 1 year
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Not Provided
Not Provided

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
Both
20 Years to 75 Years
No
Contact: Hirohito Tada, MD +81-6-6929-1221 htada@attglobal.net
Japan
 
NCT00139971
WJTOG0101
Not Provided
Not Provided
West Japan Thoracic Oncology Group
Not Provided
Principal Investigator: Hirohito Tada, MD West Japan Thoracic Oncology Group
West Japan Thoracic Oncology Group
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP