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Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prosepective Analysis


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prosepective Analysis


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Michael A. Maddaus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Federal Government

Study ID:

CDR0000065576

NCT ID:

NCT00003006

Start Date:

May 1997

Completion Date:

June 2010

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
University of Minnesota Medical SchoolMinneapolis, Minnesota  55455