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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004859 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: thalidomide Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III NSCLC |
Estimated Enrollment: | 588 |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms.
Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy 5 days a week for 6 weeks. Arm II patients continue oral thalidomide.
Patients are followed every 2 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 588 patients will be accrued for this study within 7 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma
Unresectable stage IIIA
Stage IIIB disease without significant pleural effusion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Joan H. Schiller, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000067510, ECOG-3598 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004859 |
Health Authority: | United States: Food and Drug Administration |
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 adenosquamous cell lung cancer bronchoalveolar cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Thalidomide Adenocarcinoma, Bronchiolo-Alveolar Carboplatin Carcinoma Adenocarcinoma of lung |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Leprostatic Agents |