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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group National Cancer Institute of Canada |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020709 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: gefitinib Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control |
| Official Title: | A Phase III Trial Of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed By Maintenance Therapy With ZD 1839 Or Placebo In Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer |
| Study Start Date: | June 2001 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).
Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33.
Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.
Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.
Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.
Patients are followed every 6 months for 5 years and then annually for 5 years.
PROJECTED ACCRUAL: A total of 840 patients will be accrued for this study within 3.5 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed newly diagnosed single, primary bronchogenic non-small cell lung cancer (NSCLC)
Unresectable stage IIIA disease
Stage IIIB disease
Pathologically or radiographically documented positive N3 nodes
Any documented T4 lesions invading the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina
Single primary parenchymal lesion
No malignant pleural or pericardial effusions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 176 Study Locations| Study Chair: | Karen Kelly, MD | University of Colorado at Denver and Health Sciences Center |
| Study Chair: | James R. Jett, MD | Mayo Clinic |
| Study Chair: | Yee C. Ung, MD, FRCPC | Edmond Odette Cancer Centre at Sunnybrook |
More Information
| Study ID Numbers: | CDR0000068706, SWOG-S0023, CAN-NCIC-BR15, NCCTG-S0023 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020709 History of Changes |
| Health Authority: | United States: Federal Government |
|
squamous cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
|
Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Protein Kinase Inhibitors Etoposide phosphate Carcinoma Docetaxel Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Gefitinib Carcinoma, Non-Small-Cell Lung Etoposide Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Antineoplastic Agents, Phytogenic Etoposide Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |
