Non-small Cell Lung Cancer
Conditions
Keywords
Early stage lung cancer, Cervical mediastinoscopy, Observational study, clinical stage T2N0M0 and select T1N0M0 (suvMAX on FDG-PET of >/=10)
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.
Interventions
None listed
Sponsors
University of Virginia
University of North Carolina
Emory University
Jennifer Bell
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed