Sponsored by Washington University School of Medicine

Phase	Quota	Distance
Phase N/A		Near

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 Start Date: January 2008

Estimated Completion Date: December 2014

Specialties: Pulmonology: Diagnostic/Lung Function,Lung/Thoracic Oncology Oncology: Diagnostics/Radiology,Lung/Thoracic Oncology Physician Assistant: Hematology/Oncology

Interventions

No interventions cited

Inclusion criteria

• Patients must have proven or suspected clinical stage I NSCLC. Clinical stage IA (T1N0M0) patients are only allowed participation if the maxSUV of the primary tumor is >/=10. Clinical stage IB (T2N0M0) must be by size criterion only (i.e. the tumor must be > 3cm in size. Patients that have T2 tumors by visceral pleural involvement only are not eligible for the study)
• Patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach)
• Patient must have an ECOG/Zubrod score of 0, 1 or 2
• Patients must not have undergone previous invasive mediastinal staging for this cancer
• Patients must not have a tracheostomy
• Patient must have a CT of the chest and upper abdomen or an FDG-PET scan performed within 60 days of enrollment to the study that confirms their clinical stage I status. Both scans must be performed, only one needs to be within 60 days of enrollment to the study

Exclusion criteria

• There are no separately noted exclusion criteria. All criteria are listed under inclusion   

Study Locations And Contact Information

• Washington University School of Medicine, St. Louis Missouri
  
• Emory University, Atlanta Georgia
  
• University of Virginia Health System, Charlottesville Virginia
  
• University of North Carolina at Chapel Hill, Chapel Hill North Carolina