Status:
COMPLETED
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Lead Sponsor:
West Japan Thoracic Oncology Group
Conditions:
Lung Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC Stage IIIB/IV No prior treatment Measurable disease ECOG PS 0-1 Adequate organ function Age 20-74 Written informed consent
Exclusion
- Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00144066
Start Date
January 1 2003
Last Update
September 2 2005
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