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Detection of Early Metastases in Patients With Stage I Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00003006   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
May 1997
 
 
 
Complete list of historical versions of study NCT00003006 on ClinicalTrials.gov Archive Site
 
 
 
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 Prosepective 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.

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.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 3-3.5 years.

 
Interventional
Diagnostic
Lung Cancer
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: immunohistochemistry staining method
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
500
 
 

DISEASE CHARACTERISTICS:

  • Suspected or histologically confirmed previously untreated non-small cell lung cancer

    • Clinical stage I disease

      • T1 or T2 primary
      • N1 or N2 lymph nodes less than 1 cm on CT scan or negative mediastinoscopy
  • Planned thoracotomy for lobectomy or pneumonectomy

    • Video-assisted lobectomy is acceptable if no preliminary wedge resection of tumor is performed
  • No history of prior lung cancer

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 5 years since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 5 years since prior radiotherapy
  • No prior mediastinal or chest radiotherapy

Surgery:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003006
 
CDR0000065576, CLB-9761
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Michael A. Maddaus, MD Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP