Endobronchial Ultrasound Versus Mediastinoscopy in Patients With 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