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

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:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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.

Estimated Enrollment:	111
Study Start Date:	January 2008

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:

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.

Contacts and Locations

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

Contacts

Contact: Jennifer M Bell, RN, BSN	314-747-6969	bellj@wudosis.wustl.edu
Contact: Joanne F Musick, RN, BSN	314-747-0707	musickj@wustl.edu

Locations

United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Felix Fernandez, MD 404-778-5345 felix.fernandez@emoryhealthcare.org
Sub-Investigator: Seth Force, MD
Sub-Investigator: Dan Miller, MD
Sub-Investigator: Allan Pickens, MD
Principal Investigator: Felix G Fernandez, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jennifer M Bell, RN, BSN 314-747-6969 bellj@wudosis.wustl.edu
Contact: Joanne F Musick, RN, BSN 314-747-0707 musickj@wustl.edu
Sub-Investigator: Traves D Crabtree, MD
Sub-Investigator: G. Alexander Patterson, MD
Sub-Investigator: Daniel Kreisel, MD, PhD
Sub-Investigator: A. Sasha Krupnick, MD
Sub-Investigator: Varun Puri, MD
Principal Investigator: Bryan F Meyers, MD, MPH
United States, North Carolina
University of North Carolina at Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27509
Contact: Nirmal K Veeramachaneni, MD 919-966-3383 nirmal_veeramachaneni@med.unc.edu
Principal Investigator: Nirmal K Veeramachaneni, MD
United States, Virginia
University of Virginia Health System	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Benjamin Kozower, MD 434-924-2145 BDK8G@hscmail.mcc.virginia.edu
Sub-Investigator: David Jones, MD
Sub-Investigator: Christine Lau, MD
Principal Investigator: Benjamin Kozower, MD

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:

Meyers BF, Haddad F, Siegel BA, Zoole JB, Battafarano RJ, Veeramachaneni N, Cooper JD, Patterson GA. Cost-effectiveness of routine mediastinoscopy in computed tomography- and positron emission tomography-screened patients with stage I lung cancer. J Thorac Cardiovasc Surg. 2006 Apr;131(4):822-9; discussion 822-9. Epub 2006 Mar 2.

Reed CE, Harpole DH, Posther KE, Woolson SL, Downey RJ, Meyers BF, Heelan RT, MacApinlac HA, Jung SH, Silvestri GA, Siegel BA, Rusch VW; American College of Surgeons Oncology Group Z0050 trial. Results of the American College of Surgeons Oncology Group Z0050 trial: the utility of positron emission tomography in staging potentially operable non-small cell lung cancer. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1943-51.

Hammoud Z, Anderson RC, Meyers BF, et al. The current role of mediastinoscopy in the evaluation of thoracic disease. J Thorac Cardiovasc Surg 1999; 118:894-9.

Gonzalez-Stawinski GV, Lemaire A, Merchant F, O'Halloran E, Coleman RE, Harpole DH, D'Amico TA. A comparative analysis of positron emission tomography and mediastinoscopy in staging non-small cell lung cancer. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1900-5.

Cerfolio RJ, Bryant AS, Ohja B, Bartolucci AA. The maximum standardized uptake values on positron emission tomography of a non-small cell lung cancer predict stage, recurrence, and survival. J Thorac Cardiovasc Surg. 2005 Jul;130(1):151-9.

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:	October 4, 2011
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013