Trial Information
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Inclusion Criteria:
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 Criteria:
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Over all survival
Principal Investigator
Toyoaki Hida, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
West Japan Thoracic Onoclogy Group
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
WJTOG0203
NCT ID:
NCT00144066
Start Date:
January 2003
Completion Date:
Related Keywords:
- Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms