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NCT00144066 Clinical Trial

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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00144066
Other study ID # WJTOG0203
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated September 1, 2005
Start date January 2003

Study information
Verified date September 2005
Source West Japan Thoracic Oncology Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• platinum-based chemotherapy alone (up to six cycles)

• platinum-based chemotherapy followed by maintenance therapy with gefitinib

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary Over all survival
Secondary Time to disease progression
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