Lung CancerNCT00003006
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- reverse transcriptase-polymerase chain reaction and immunohistochemistry staining method
- How many people
- 501 participants
- Where
- 10 sitesUnited States
- Study dates
- May 1997to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer.
- Clinical stage I proven or suspected new non-small cell lung carcinoma T1 or T2 primary N1 or N2 lymph nodes <1cm on CT or negative mediastinoscopy
- ≥ 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Barnes-Jewish Hospital
St Louis, Missouri, 63110
State University of New York - Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prospective Analysis
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.
Read the detailed description
OBJECTIVES:
- 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
- Lung Cancer
- Being tested
- reverse transcriptase-polymerase chain reaction, immunohistochemistry staining method
- Keywords
- stage I non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse transcriptase-polymerase chain reactionGenetic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: reverse transcriptase-polymerase chain reaction; Other: immunohistochemistry staining method |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study startMay 1997
- Primary completionMar 2002
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Maddaus, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003006
- Sponsor's protocol ID
- CALGB-9761
- Other IDs
- U10CA031946, CLB-9761, CDR0000065576
- Status last verified
- Jun 2016
- First submitted
- 1 Nov 1999
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16899777Maddaus 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.
PubMed 15829324D'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.
PubMed 14654545D'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.
PubMed 11882819
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prospective Analysis
- ClinicalTrials.gov ID
- NCT00003006
- Acronym / sponsor ID
- CALGB-9761
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1997
- Primary completion
- Mar 2002 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: reverse transcriptase-polymerase chain reaction, Other: immunohistochemistry staining methodAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reverse transcriptase-polymerase chain reaction | Genetic | Group 1 |
| immunohistochemistry staining method | Other | Group 1 |
Primary outcome
overall survival
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 16899777Potti 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.
- Results publicationMaddaus 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.
- Results publication: PubMed 15829324D'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.
- Results publicationD'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.
- Results publication: PubMed 14654545Vollmer 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.
- Results publication: PubMed 11882819D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Maddaus, MD study chair
Masonic Cancer Center, University of Minnesota
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003006, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.