Utility of Routine Cervical Mediastinoscopy in Clinical Stage I Non-Small Cell Lung Cancer (NSCLC)
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | January 2008 |
| Contact: | Jennifer M Bell, RN, BSN |
| Email: | bellj@wudosis.wustl.edu |
| Phone: | 314-747-6969 |
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.
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.
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.
We found this trial at
4
sites
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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