Status:
UNKNOWN
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
Lead Sponsor:
West Japan Thoracic Oncology Group
Conditions:
Lung Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief 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
- completely resected non small cell lung cancer
- no prior anti cancer treatment for thoracic malignancy exept for this operation
- pathological stage IB, II, and stage IIIA with only one station of n2 disease
- PS 0-1
- age 20-75
- adequate organ function for chemotherapy
- written informed consent
Exclusion
- small cell lung cancer or low grade malignancy of lung cancer
- incomplete resection
- apparent interstitial pneumonitis at chest rentogenogram
- inadequate condition for chemotherapy
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00139971
Start Date
December 1 2001
Last Update
January 6 2006
Active Locations (1)
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1
Osaka City General Hospital
Osaka, Osaka, Japan, 531-0021