Utility of Routine Cervical Mediastinoscopy in Clinical Stage I Non-Small Cell Lung Cancer (NSCLC)

Sponsored by Washington University School of Medicine

Phase Quota
Phase N/A

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


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

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