Clinical trial NCT01146366: Utility of Routine Cervical Mediastinoscopy in Clinical Stage I Non-Small Cell Lung Cancer (NSCLC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Early stage lung cancer
Cervical mediastinoscopy
Observational study
clinical stage T2N0M0 and select T1N0M0 (suvMAX on FDG-PET of >/=10)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: University of North Carolina
name: Emory University
First posted: 2010-06-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of occult N2/3 metastases in the study population
timeFrame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.
Secondary outcomes:
measure: Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases
timeFrame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Washington University School of Medicine
name: Bryan F Meyers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jtcvs.2005.10.045. Epub 2006 Mar 2.
citation: 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. doi: 10.1016/j.jtcvs.2003.07.030.
citation: Hammoud ZT, Anderson RC, Meyers BF, Guthrie TJ, Roper CL, Cooper JD, Patterson GA. The current role of mediastinoscopy in the evaluation of thoracic disease. J Thorac Cardiovasc Surg. 1999 Nov;118(5):894-9. doi: 10.1016/s0022-5223(99)70059-0.
citation: 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. doi: 10.1016/s0022-5223(03)01036-5.
citation: 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. doi: 10.1016/j.jtcvs.2004.11.007.
citation: Fernandez FG, Kozower BD, Crabtree TD, Force SD, Lau C, Pickens A, Krupnick AS, Veeramachaneni N, Patterson GA, Jones DR, Meyers BF. Utility of mediastinoscopy in clinical stage I lung cancers at risk for occult mediastinal nodal metastases. J Thorac Cardiovasc Surg. 2015 Jan;149(1):35-41, 42.e1. doi: 10.1016/j.jtcvs.2014.08.075. Epub 2014 Sep 17.