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A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer


N/A
21 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer


This is a prospective randomized clinical trial of males and females age 21 or older being
evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each
arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample
size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study
design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or
not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more
lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%.
This study requires subjects to agree to the selection of their standard of care procedure.
Subjects will be randomized (stratified computer generated randomization stratified y center
and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata).
Randomization will use variable block sizes (4-8), so that randomization allocation remains
concealed as investigators will not be blinded. This study requires subjects to consent to
the release of outcome data and follow-up data to be used for study analysis. No additional
visit will be required for this study; this study will not require any additional time
requirements beyond their scheduled evaluations.


Inclusion Criteria:



- Age 21 years or greater

- Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection

- Known or suspected non-small cell carcinoma of the lung eligible for resection

- CT scan performed within 45 days prior to evaluation for study participation

- PET scan performed within 45 days prior to evaluation for study participation

Exclusion Criteria:

- Pathologically proven metastatic disease

- History of malignancy within 5 years other than (skin) basal cell carcinoma

- Enlarged ipsilateral mediastinal lymph nodes > 2.5 cm in diameter

- Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques.

Outcome Time Frame:

Post operative

Safety Issue:

No

Principal Investigator

Brenda Hoffman, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Institutional Review Board

Study ID:

09-002240

NCT ID:

NCT00970645

Start Date:

February 2010

Completion Date:

March 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non small cell lung cancer
  • mediastinum
  • endobronchial ultrasound fine needle aspiration
  • endoscopic ultrasound
  • mediastinoscopy
  • surgical or minimally invasive evaluation of mediastinum
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Mayo Clinic Rochester, Minnesota  55905
Medical University of South Carolina Charleston, South Carolina  29425-0721
Mayo Clinic Jacksonville, Florida  32224