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

September 1, 2005 updated by: West Japan Thoracic Oncology Group

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.

Study Overview

Status

Completed

Conditions

Lung Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Over all survival

Secondary Outcome Measures

Outcome Measure
Time to disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Japan Thoracic Oncology Group

Investigators

Principal Investigator: Toyoaki Hida, MD, PhD, West Japan Thoracic Onoclogy Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2005

Last Update Submitted That Met QC Criteria

September 1, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

WJTOG0203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.