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Prospective Comparison of Endobronchial Ultrasound Needle Biopsy Versus Mediastinoscopy for Staging of Mediastinal Nodes in Patients With Clinical Stage IIIA Non-Small Cell Lung Cancer (NSCLC)


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Prospective Comparison of Endobronchial Ultrasound Needle Biopsy Versus Mediastinoscopy for Staging of Mediastinal Nodes in Patients With Clinical Stage IIIA Non-Small Cell Lung Cancer (NSCLC)


The current procedure used to check for cancer cells in the lungs is a small operation at
the base of the neck (mediastinoscopy) to get samples of the lymph glands. These samples are
then looked at under the microscope to see if they contain cancer cells. A procedure has
been developed that may allow doctors to get samples of lymph glands without having to
perform an operation. This is called endobronchial ultrasound or "EBUS". The purpose of this
study is to compare the 2 procedures.

If you agree to take part in this study, your insurance provider will be contacted. In
order for you to take part in this study, your insurance provider must agree to pay for both
the EBUS and mediastinoscopy procedures.

If your insurance provider agrees to pay for both procedures, you will be scheduled for the
EBUS and a mediastinoscopy. The procedures will not be scheduled on the same day. You will
first have the EBUS. You will receive general anesthesia and a small flexible scope will be
passed down your windpipe. Samples of your lymph gland tissue will then be collected through
a tiny needle that is passed through the scope. This will be performed as an out patient
procedure.

If a tumor is found on the opposite side of your chest from another tumor by the EBUS, a
mediastinoscopy will not be necessary.

If a tumor is not found on the opposite side of your chest from another tumor by the EBUS,
you will then have a mediastinoscopy. This is also an outpatient procedure that will involve
a small (2 cm) cut at the base of the neck, just above the breast bone. Your doctor will
then pass a special scope with a camera into your chest (below the breast bone). This will
allow your doctor to see the lymph glands around your windpipe and get samples of them. This
will also be performed under general anesthesia and you will be able to leave the hospital
shortly after the procedure.

Depending on whether or not the lymph glands have cancer in them, your doctor will then
recommend the best therapy for the tumor to you.

This is an investigational study. The EBUS is FDA approved. The mediastinoscopy is
considered standard of care. The comparison of the 2 procedures is investigational.

Up to 100 patients will be take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patient must be >/= 18 years old.

2. Patient must have ECOG/Zubrod status 0, 1, or 2.

3. Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma,
sarcomatoid, neuroendocrine or large cell) and be clinical Stage IIIa, according to
the 1998 staging system of the American Joint Commission on Cancer for lung cancer.

4. Patient must have proven or suspected NSCLC prior to registration. Patients who
obtain subsequent pathologic confirmation of NSCLC at the time of EBUS or subsequent
surgery will remain enrolled on the study. Patients subsequently found to have an
etiology other than NSCLC will be excluded from further analysis.

5. Patient must be anticipated to have definitive therapy for primary NSCLC. This may
include surgery, chemotherapy, radiation therapy or a combination the above.

6. Patient must be medically fit for definitive therapy.

7. Patient or the patient's legally acceptable representative must provide a signed and
dated written informed consent prior to registration and any study-related
procedures.

Exclusion Criteria:

1. Patient has received prior chemotherapy or radiotherapy for this cancer.

2. Patient is considered a poor risk due to non-malignant systemic disease
(cardiovascular, renal, etc.) that would preclude the treatment options.

3. Patient has contraindication to either endobronchial ultrasound or mediastinoscopy
such as: Latex allergy; Bleeding diathesis; Previous mediastinoscopy; Previous
mediastinal nodal resection; Previous tracheostomy.

4. Patients malignancy not consistent with NSCLC

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

David C. Rice, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0353

NCT ID:

NCT00559611

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Lung Cancer
  • Lung Cancer
  • Endobronchial Ultrasound
  • Fine Needle Aspiration
  • Mediastinoscopy
  • EBUS-FNA
  • EBUS
  • Needle Biopsy
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030