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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
Conditions
Lung Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
Type: Drug
Name: UFT 250mg/m2, daily for 1 year
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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
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
Location
Osaka City General Hospital
Osaka, Japan
Status: Recruiting
Contact: Hirohito Tada, MD - +81-6-6929-1221 - htada@attglobal.net
Start Date
December 2001
Sponsors
West Japan Thoracic Oncology Group
Source
West Japan Thoracic Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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