Status:
COMPLETED
Utility of Routine Cervical Mediastinoscopy in Clinical Stage I Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Jennifer Bell
Collaborating Sponsors:
University of Virginia
University of North Carolina
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- There are no separately noted exclusion criteria. All criteria are listed under inclusion.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01146366
Start Date
January 1 2008
End Date
December 1 2014
Last Update
December 11 2014
Active Locations (4)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27509
4
University of Virginia Health System
Charlottesville, Virginia, United States, 22908