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CompletedNCT00003006Updated Jun 29, 2016

Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer

An observational study in Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by Alliance for Clinical Trials in Oncology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
501
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Lung Cancer

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Keywords

  • stage I non-small cell lung cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 501 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with non-small cell lung cancer.

Eligibility criteria

  • 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
501 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Genetic: reverse transcriptase-polymerase chain reaction · Other: immunohistochemistry staining method

Interventions

  • Geneticreverse transcriptase-polymerase chain reaction
  • Otherimmunohistochemistry staining method
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What researchers measure

Primary outcomes

  1. overall survival

    Time frame: up to 5 years

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Study locations

10 sites
  • 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
    Saint 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
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References and documents

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. Erratum In: N Engl J Med. 2007 Jan 11;356(2):201-2. PubMed 16899777 ↗
  • 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. PubMed 15829324 ↗
  • 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. PubMed 14654545 ↗
  • 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. PubMed 11882819 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00003006
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 13, 2003
Start date
May 1997
Primary completion
Mar 2002
Completion
Jun 2010
Last update
Jun 29, 2016

Study contacts

Michael Maddaus, MD
study chair · Masonic Cancer Center, University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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