To prospectively look at the utility of routine cervical mediastinoscopy (lymph node biopsy) in patients with clinically staged T2N0M0 NSCLC, as well as patients with clinically staged T1N0M0 NSCLC with a high maxSUV of the primary tumor on PET imaging. Hypothesis #1: The prevalence of mediastinal lymph node metastases detectable by cervical mediastinoscopy is sufficiently low (\<10%) to not support the routine use of this test in the study population. Hypothesis #2: The preoperative detection of occult(hidden) N2 lymph node metastases by cervical mediastinoscopy in patients with clinically staged T2N0M0 NSCLC or T1N0M0 NSCLC with maxSUV \>10 on PET does not provide a survival benefit when compared to detection of occult N2 lymph node metastases at the time of thoracotomy using nodal dissection or systematic sampling.
Study Type
OBSERVATIONAL
Enrollment
111
Emory University
Atlanta, Georgia, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Prevalence of occult N2/3 metastases in the study population
Prevalence of occult N2/3 metastases in the study population. This is the fraction of enrolled patients with N2/3 metastases detected by either mediastinoscopy or by systematic sampling/dissection.
Time frame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.
Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases
Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases. This is the number of patients with positive mediastinoscopy divided by the total number with N2/3 disease detected by either mediastinoscopy or by systematic sampling/dissection.
Time frame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.
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