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Utility of Routine Cervical Mediastinoscopy in Clinically Staged T2N0M0 and Select T1N0M0 Non-Small Cell Lung Cancers by FDG-PET and CT Scans


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Utility of Routine Cervical Mediastinoscopy in Clinically Staged T2N0M0 and Select T1N0M0 Non-Small Cell Lung Cancers by FDG-PET and CT Scans


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence of occult N2/3 metastases in the study population

Outcome Description:

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.

Outcome Time Frame:

After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.

Safety Issue:

No

Principal Investigator

Bryan F Meyers, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

08-0020

NCT ID:

NCT01146366

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Early stage lung cancer
  • Cervical mediastinoscopy
  • Observational study
  • clinical stage T2N0M0 and select T1N0M0 (suvMAX on FDG-PET of >/=10)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Emory UniversityAtlanta, Georgia  30322
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
University of Virginia Health SystemCharlottesville, Virginia  22903