Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC)

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

The goal of this clinical research study is to compare 2 different methods for checking lymph glands (in the middle of the chest) for cancer cells. Objectives: The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the 'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung cancer. Primary Objective: To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases. Secondary Objectives: To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes (number and location of nodes biopsied, number and location of positive nodes, extracapsular extension, ability to biopsy contralateral nodes). To determine the frequency of change of planned therapeutic management resulting from outcome of EBUS-FNA and mediastinoscopy. To determine procedure related complications. To perform analysis of cost between EBUS-FNA and mediastinoscopy.

Key facts

Study ID: NCT00559611
Run by: M.D. Anderson Cancer Center
People needed: 53
Starts: 2007-10-19
Expected to finish: 2018-03-22
Last updated by the study team: 2018-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be >/= 18 years old.
Patient must have ECOG/Zubrod status 0, 1, or 2.
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.
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.
Patient must be anticipated to have definitive therapy for primary NSCLC. This may include surgery, chemotherapy, radiation therapy or a combination the above.
Patient must be medically fit for definitive therapy.
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.

You may not qualify if…

Patient has received prior chemotherapy or radiotherapy for this cancer.
Patient is considered a poor risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: Latex allergy; Bleeding diathesis; Previous mediastinoscopy; Previous mediastinal nodal resection; Previous tracheostomy.
Patients malignancy not consistent with NSCLC

Where it is running

University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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