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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146366
• Other study ID #: 08-0020
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: December 10, 2014
• Start date: January 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Jennifer Bell	Emory University, University of North Carolina, University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Epub 2006 Mar 2. — View 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. Erratum in: J Thorac Cardiovasc Surg. 2007 Apr;133(4):864. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of occult N2/3 metastases in the study population	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.	After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.	No
Secondary	Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases	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.	After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.	No