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

This study has been completed.
Sponsor:
Collaborators:
University of Virginia
University of North Carolina
Emory University
Information provided by (Responsible Party):
Jennifer Bell, Washington University
ClinicalTrials.gov Identifier:
NCT01146366
First received: June 10, 2010
Last updated: December 10, 2014
Last verified: December 2014
  Purpose

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.


Condition
Non-small Cell Lung Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 111
Study Start Date: January 2008
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146366

Locations
United States, Georgia
Emory University
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
Sponsors and Collaborators
Jennifer Bell
University of Virginia
University of North Carolina
Emory University
Investigators
Principal Investigator: Bryan F Meyers, MD, MPH Washington University School of Medicine
  More Information

Publications:
Responsible Party: Jennifer Bell, Manager of Research, Cardiothoracic Surgery, Washington University
ClinicalTrials.gov Identifier: NCT01146366     History of Changes
Other Study ID Numbers: 08-0020
Study First Received: June 10, 2010
Last Updated: December 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Early stage lung cancer
Cervical mediastinoscopy
Observational study
clinical stage T2N0M0 and select T1N0M0 (suvMAX on FDG-PET of >/=10)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015