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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

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ClinicalTrials.gov Identifier: NCT00144066
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 2, 2005
Sponsor:
Information provided by:
West Japan Thoracic Oncology Group

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: platinum-based chemotherapy alone (up to six cycles) Drug: platinum-based chemotherapy followed by maintenance therapy with gefitinib Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib




Primary Outcome Measures :
  1. Over all survival

Secondary Outcome Measures :
  1. Time to disease progression


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144066


Sponsors and Collaborators
West Japan Thoracic Oncology Group
Investigators
Principal Investigator: Toyoaki Hida, MD, PhD West Japan Thoracic Onoclogy Group

ClinicalTrials.gov Identifier: NCT00144066     History of Changes
Other Study ID Numbers: WJTOG0203
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 2, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action