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

This study has been completed.
Sponsor:
Information provided by:
West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:
NCT00144066
First received: August 31, 2005
Last updated: September 1, 2005
Last verified: September 2005
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by West Japan Thoracic Oncology Group:

Primary Outcome Measures:
  • Over all survival

Secondary Outcome Measures:
  • Time to disease progression

Estimated Enrollment: 600
Study Start Date: January 2003
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144066

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00144066     History of Changes
Other Study ID Numbers: WJTOG0203
Study First Received: August 31, 2005
Last Updated: September 1, 2005
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 20, 2014