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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003006 |
RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer.
PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated.
Condition | Intervention |
Lung Cancer |
Procedure: immunohistochemistry staining method Procedure: reverse transcriptase-polymerase chain reaction |
MedlinePlus related topics: | Cancer Lung Cancer |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prosepective Analysis |
Estimated Enrollment: | 500 |
Study Start Date: | May 1997 |
OBJECTIVES:
OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 3-3.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Suspected or histologically confirmed previously untreated non-small cell lung cancer
Clinical stage I disease
Planned thoracotomy for lobectomy or pneumonectomy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Iowa | |||||
Holden Comprehensive Cancer Center at The University of Iowa | |||||
Iowa City, Iowa, United States, 52242-1009 | |||||
United States, Maryland | |||||
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, Minnesota | |||||
University of Minnesota Cancer Center | |||||
Minneapolis, Minnesota, United States, 55455 | |||||
University of Minnesota Medical School | |||||
Minneapolis, Minnesota, United States, 55455 | |||||
United States, Missouri | |||||
Barnes-Jewish Hospital | |||||
Saint Louis, Missouri, United States, 63110 | |||||
Ellis Fischel Cancer Center - Columbia | |||||
Columbia, Missouri, United States, 65203 | |||||
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 | |||||
State University of New York - Upstate Medical University | |||||
Syracuse, New York, United States, 13210 | |||||
United States, North Carolina | |||||
Duke Comprehensive Cancer Center | |||||
Durham, North Carolina, United States, 27710 | |||||
Lineberger Comprehensive Cancer Center, UNC | |||||
Chapel Hill, North Carolina, United States, 27599-7295 |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Study Chair: | Michael A. Maddaus, MD | Masonic Cancer Center, University of Minnesota |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065576, CLB-9761 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003006 |
Health Authority: | United States: Federal Government |
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