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

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT01146366
• Lead Sponsor: Jennifer Bell

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-17
• Primary Completion: 2014-10
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of occult N2/3 metastases in the study population	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases	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.

Trial Locations

Locations (4)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States