Utility of Routine Cervical Mediastinoscopy in Clinical Stage I Non-Small Cell Lung Cancer (NSCLC)
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.
Non-small Cell Lung Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Utility of Routine Cervical Mediastinoscopy in Clinically Staged T2N0M0 and Select T1N0M0 Non-Small Cell Lung Cancers by FDG-PET and CT Scans|
- Prevalence of occult N2/3 metastases in the study population [ Time Frame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012. ] [ Designated as safety issue: No ]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.
- Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases [ Time Frame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012. ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2008|
|Study Completion Date:||December 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146366
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27509|
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Bryan F Meyers, MD, MPH||Washington University School of Medicine|