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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003901 |
RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.
PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Procedure: biopsy Procedure: immunohistochemistry staining method |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma |
Estimated Enrollment: | 1200 |
Study Start Date: | July 1999 |
OBJECTIVES:
OUTLINE: All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed.
Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods.
Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 1200 patients will be accrued for this study over 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage I, IIA, IIB, or IIIA non-small cell lung cancer (NSCLC)
Clinically resectable disease
Thoracotomy with intention of complete resection planned
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Robbin G. Cohen, MD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067072, ACOSOG-Z0040 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003901 |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer squamous cell lung cancer |
large cell lung cancer stage IIIA non-small cell lung cancer adenocarcinoma of the lung |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma of lung Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Neoplasm Metastasis Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Site Neoplasms by Histologic Type |