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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028938 |
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. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: epoetin alfa Drug: paclitaxel Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa (Procrit) on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued for this study within 1.7-2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
If hemoglobin is 11.0-11.9 g/dL then the following lab values are required:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 |
Study Chair: | Arthur William Blackstock, MD | Wake Forest University |
Study ID Numbers: | CDR0000069148, CCCWFU-62299, CCCWFU-BG01-193, NCI-P01-0200 |
Study First Received: | January 4, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00028938 |
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 |
Epoetin Alfa Thoracic Neoplasms Non-small cell lung cancer 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 Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Hematinics Antineoplastic Agents Hematologic Agents Mitosis Modulators |
Antimitotic Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |