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Study Summary
No. 2007-0387:.......Lung......George A. Eapen......Pulmonary Medicine
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Study Summary Title
Study Summary
Number:		2007-0387
Study Title:Diagnostic utility of endobronchial ultrasound guided mediastinal lymph node sampling in clinical Stage I and II Non Small Cell Lung Cancer
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Physician New Patient Referral
Name:George A. EapenPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Pulmonary MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-4017
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Not dictated per protocol.
Treatment
Agents:		NoneHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Patients are not hospitalized unless there is a complication.
Description/
Intervention:		The goal of this clinical research study is to learn how accurately an
endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may
detect mediastinal lymph node metastases in patients with clinical stage I and
II non-small cell lung cancer (NSCLC).
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Study Objectives / Outcomes
This study is designed to evaluate the added utility of endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) over PET and CT (or PET/CT) for detecting mediastinal lymph node metastases in clinical early stage lung cancer. The endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) is FDA approved for this purpose.

PRIMARY OBJECTIVES

1. Determine the sensitivity, specificity and diagnostic accuracy of EBUS TBNA in detecting mediastinal nodal metastasis among patients with clinical stage I and II non small cell lung cancer

SECONDARY OBJECTIVES

1. Identify predictors of mediastinal nodal metastasis in patients with early stage NSCLC
2. To determine the frequency of change of planned therapeutic management resulting from outcome of EBUS-FNA.
3. To determine procedure related complications.
4. To perform cost analysis of a diagnostic algorithm that incorporates EBUS-TBNA in the work up of early stage lung cancer
5. Estimate the prevalence of unsuspected mediastinal nodal metastasis in patients with clinical stage I and II non small cell lung cancer.
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    Study Status Information
    Study Activation / Registration Date:
    IRB Review and Approval Date:04/06/2009
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Open
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Patient must be >/= 18 years old.

    2) Patient must have ECOG/Zubrod status 0-2.

    3) Patient must have proven or suspected NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1).

    4) Patient must be eligible for definitive surgical therapy for primary NSCLC.

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

    6) If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a. Patient has undergone potentially curative therapy for all prior malignancies. b. No evidence of active / recurrent disease.

    7) All females of childbearing age must have a negative pregnancy test before beginning the study.
    Exclusion Criteria:1) Patient has received prior chemotherapy or radiotherapy for this cancer.

    2) Patient is considered a poor risk for surgery 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: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.

    4) Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.

    5) Patient has two seperate same histology lung tumors (where the question of two seperate primaries or metastatic disease makes definitive clinical staging inaccurate).

    6) Females who are pregnant and/or lactating.
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    Links
    Registration Number: NCT00832715
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center