Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
NCT ID: NCT00003006
Last Updated: 2016-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
501 participants
OBSERVATIONAL
1997-05-31
2010-06-30
Brief Summary
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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.
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Detailed Description
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* Determine whether the presence of occult micrometastases (OM) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer.
* Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to detect CEA mRNA) in these patients.
* Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients.
* Determine the relationship between tumor size (or T-stage) and the presence of OM detected by immunohistochemistry or RT-PCR in these patients.
* Determine the relationship between the presence of OM and disease-free survival in these patients.
* Determine the relationship between the site of OM and incidence of recurrence, site of recurrence, and survival of these patients.
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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1
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.
reverse transcriptase-polymerase chain reaction
immunohistochemistry staining method
Interventions
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reverse transcriptase-polymerase chain reaction
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
* ≥ 5 years since prior chemo or XRT; no prior mediastinal or chest XRT.
* ≥ 18 years of age
* No history of previous lung cancer or concomitant malignancy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Michael Maddaus, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Countries
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References
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Potti A, Mukherjee S, Petersen R, Dressman HK, Bild A, Koontz J, Kratzke R, Watson MA, Kelley M, Ginsburg GS, West M, Harpole DH Jr, Nevins JR. A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med. 2006 Aug 10;355(6):570-80. doi: 10.1056/NEJMoa060467.
Maddaus MA, Wang X, Vollmer RT, et al.: CALGB 9761: a prospective analysis of IHC and PCR based detection of occult metastatic disease in stage I NSCLC. [Abstract] J Clin Oncol 24 (Suppl 18): A-7030, 371s, 2006.
D'Cunha J, Herndon JE 2nd, Herzan DL, Patterson GA, Kohman LJ, Harpole DH, Kernstine KH, Kern JA, Green MR, Maddaus MA, Kratzke RA; Cancer and Leukemia Group B. Poor correspondence between clinical and pathologic staging in stage 1 non-small cell lung cancer: results from CALGB 9761, a prospective trial. Lung Cancer. 2005 May;48(2):241-6. doi: 10.1016/j.lungcan.2004.11.006. Epub 2005 Jan 4.
D'Cunha J, Herndon JL, Herzan DL, et al.: Poor correlation between clinical and pathological staging in stage I non-small cell lung cancer: results from CALGB 9761, a prospective trial. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2550, 634, 2003.
Vollmer RT, Herndon JE 2nd, D'Cunha J, Abraham NZ, Solberg J, Fatourechi M, Maruska A, Kern JA, Green MR, Kratzke RA, Maddaus MA; Cancer and Leukemia Group B Trial 9761. Immunohistochemical detection of occult lymph node metastases in non-small cell lung cancer: anatomical pathology results from Cancer and Leukemia Group B Trial 9761. Clin Cancer Res. 2003 Nov 15;9(15):5630-5.
D'Cunha J, Corfits AL, Herndon JE 2nd, Kern JA, Kohman LJ, Patterson GA, Kratzke RA, Maddaus MA. Molecular staging of lung cancer: real-time polymerase chain reaction estimation of lymph node micrometastatic tumor cell burden in stage I non-small cell lung cancer--preliminary results of Cancer and Leukemia Group B Trial 9761. J Thorac Cardiovasc Surg. 2002 Mar;123(3):484-91; discussion 491. doi: 10.1067/mtc.2002.119883.
Other Identifiers
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CLB-9761
Identifier Type: -
Identifier Source: secondary_id
CDR0000065576
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9761
Identifier Type: -
Identifier Source: org_study_id
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