Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prosepective Analysis
18 Years
N/A
Both
Lung Cancer
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 Center | New York, New York 10021 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
| University of Minnesota Medical School | Minneapolis, Minnesota 55455 |
