Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Genetic: reverse transcriptase-polymerase chain reactionOther: immunohistochemistry staining method
- Registration Number
- NCT00003006
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 immunohistochemistry staining method 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. Group 1 reverse transcriptase-polymerase chain reaction 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.
- Primary Outcome Measures
Name Time Method overall survival up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States