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Trial Title:
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
NCT ID:
NCT00139971
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Gemcitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
Intervention type:
Drug
Intervention name:
UFT 250mg/m2, daily for 1 year
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:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Osaka City General Hospital
Address:
City:
Osaka
Zip:
531-0021
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Hirohito Tada, MD
Phone:
+81-6-6929-1221
Email:
htada@attglobal.net
Investigator:
Last name:
Hirohito Tada, MD
Email:
Principal Investigator
Start date:
December 2001
Lead sponsor:
Agency:
West Japan Thoracic Oncology Group
Agency class:
Other
Source:
West Japan Thoracic Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00139971
http://www.wjtog.org/
