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A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer


Phase 3
20 Years
74 Years
Not Enrolling
Both
Lung Cancer

Thank you

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

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