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

Phase 3

• Conditions: Lung Cancer

• Registration Number: NCT00139971
• Lead Sponsor: West Japan Thoracic Oncology Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Status Verified: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Last Update Submitted: 2006-01-05
• Last Update Posted: 2006-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5 year survival rate

Secondary Outcome Measures

Name	Time	Method
Disease free survival

Trial Locations

Locations (1)

Osaka City General Hospital; 🇯🇵 Osaka, Japan