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

December 10, 2014 updated by: Jennifer Bell

Utility of Routine Cervical Mediastinoscopy in Clinically Staged T2N0M0 and Select T1N0M0 Non-Small Cell Lung Cancers by FDG-PET and CT Scans

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27509
        • University of North Carolina at Chapel Hill
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being evaluated by a thoracic surgeon for surgical resection of clinical stage I non-small cell lung cancer

Description

Inclusion Criteria:

  1. 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).
  2. Patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach).
  3. Patient must have an ECOG/Zubrod score of 0, 1 or 2.
  4. Patients must not have undergone previous invasive mediastinal staging for this cancer.
  5. Patients must not have a tracheostomy.
  6. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennifer Bell

Collaborators

Emory University
University of Virginia
University of North Carolina

Investigators

  • Principal Investigator: Bryan F Meyers, MD, MPH, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (ESTIMATE)

June 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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