Back to resultsA Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
platinum-based chemotherapy alone (up to six cycles)
platinum-based chemotherapy followed by maintenance therapy with gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Over all survival
Secondary Outcome Measures
Time to disease progression
Full Information
NCT ID
NCT00144066
First Posted
August 31, 2005
Last Updated
September 1, 2005
Sponsor
West Japan Thoracic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00144066
Brief Title
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Official Title
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
West Japan Thoracic Oncology Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
platinum-based chemotherapy alone (up to six cycles)
Intervention Type
Drug
Intervention Name(s)
platinum-based chemotherapy followed by maintenance therapy with gefitinib
Primary Outcome Measure Information:
Title
Over all survival
Secondary Outcome Measure Information:
Title
Time to disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toyoaki Hida, MD, PhD
Organizational Affiliation
West Japan Thoracic Onoclogy Group
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.wjtog.org/
Description
Related Info
Learn more about this trial
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
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