Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prospective Analysis
4 other identifiers
observational
501
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 1997
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2002
CompletedFirst Posted
Study publicly available on registry
August 13, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJune 29, 2016
June 1, 2016
4.8 years
November 1, 1999
June 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
up to 5 years
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with non-small cell lung cancer.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (10)
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Related Publications (6)
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.
PMID: 16899777BACKGROUNDMaddaus 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.
RESULTD'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.
PMID: 15829324RESULTD'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.
RESULTVollmer 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.
PMID: 14654545RESULTD'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.
PMID: 11882819RESULT
Biospecimen
Patients enrolled onto CALGB 9761 will have, at the time of thoracotomy (or video assisted lobectomy) and pulmonary resection, samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Maddaus, MD
Masonic Cancer Center, University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
August 13, 2003
Study Start
May 1, 1997
Primary Completion
March 1, 2002
Study Completion
June 1, 2010
Last Updated
June 29, 2016
Record last verified: 2016-06