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

NCT01146366 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2014-12-11

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Jennifer Bell

    lead OTHER

Principal Investigators

  • Bryan F Meyers, MD, MPH · Washington University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01146366 on ClinicalTrials.gov