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

NCT00559611 | Completed

• 2 other identifiers: 2007-0353NCI-2011-01302
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Non-Small Lung Cancer; Lung Cancer; Endobronchial Ultrasound; Fine Needle Aspiration; Mediastinoscopy; EBUS-FNA; EBUS; Needle Biopsy; NSCLC

Outcome Measures

Primary Outcomes (1)

• Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation

  Outcome defined as how many patients EBUS stage N0/1 actually end up being N2/3, and how many EBUS stage N2 actually are N3 by mediastinoscopy. Study primarily interested in an upper limit on this proportion. Primary analysis is the upper one-sided 90% confidence limit.

  2 Years

Study Arms (1)

Endobronchial Ultrasound vs. Mediastinoscopy

EXPERIMENTAL

Endobronchial Ultrasound - A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope. Mediastinoscopy - Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.

Procedure: Endobronchial Ultrasound; Procedure: Mediastinoscopy

Interventions

Endobronchial Ultrasound PROCEDURE

A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.

Also known as: EBUS

Endobronchial Ultrasound vs. Mediastinoscopy

Mediastinoscopy PROCEDURE

Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.

Endobronchial Ultrasound vs. Mediastinoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Mediastinoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• David C. Rice, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: October 19, 2007
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)