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NCT00139971 Clinical Trial

Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00139971
Other study ID # WJTOG0101
Secondary ID
Status Recruiting
Phase Phase 3
First received August 30, 2005
Last updated January 5, 2006
Start date December 2001

Study information
Verified date August 2005
Source West Japan Thoracic Oncology Group
Contact Hirohito Tada, MD
Phone +81-6-6929-1221
Email htada@attglobal.net
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6

• UFT 250mg/m2, daily for 1 year

Locations
Country Name City State
Japan Osaka City General Hospital Osaka

Sponsors (1)
Lead Sponsor Collaborator
West Japan Thoracic Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 5 year survival rate
Secondary Disease free survival
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