Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer

Study Description

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Brief Summary:

This is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo Rochester will enroll approximately 125 subjects. This study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. The consenting subjects will receive EUS and /or EBUS- guided FNA or Mediastinoscopy/Thoracoscopy.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Procedure: Mediastinoscopy/thoracoscopy; Procedure: EBUS/EUS	Not Applicable

Detailed Description:

This is a prospective randomized clinical trial of males and females age 21 or older being evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%. This study requires subjects to agree to the selection of their standard of care procedure. Subjects will be randomized (stratified computer generated randomization stratified y center and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata). Randomization will use variable block sizes (4-8), so that randomization allocation remains concealed as investigators will not be blinded. This study requires subjects to consent to the release of outcome data and follow-up data to be used for study analysis. No additional visit will be required for this study; this study will not require any additional time requirements beyond their scheduled evaluations.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer
Study Start Date :	February 2010
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: traditional mediastinoscopy/thoracoscopy; Traditional Mediastinoscopy used to detect or stage lung cancers.	Procedure: Mediastinoscopy/thoracoscopy; Mediastinoscopy used to detect/stage lung cancer.; Other Name: Lung biopsy
Active Comparator: EBUS/EUS; Minimal invasive technique for staging/detecting lung cancer.	Procedure: EBUS/EUS; Minimal invasive technique to stage/detect lung cancer.; Other Names: Endobronchial Ultrasound; Endoscopic Ultrasound

Outcome Measures

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Primary Outcome Measures :

1. Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques. [ Time Frame: Post operative ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age 21 years or greater
• Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection
• Known or suspected non-small cell carcinoma of the lung eligible for resection
• CT scan performed within 45 days prior to evaluation for study participation
• PET scan performed within 45 days prior to evaluation for study participation

Exclusion Criteria:

• Pathologically proven metastatic disease
• History of malignancy within 5 years other than (skin) basal cell carcinoma
• Enlarged ipsilateral mediastinal lymph nodes > 2.5 cm in diameter
• Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET

Contacts and Locations

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Locations

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-6300

Sponsors and Collaborators

Mayo Clinic

Medical University of South Carolina

Investigators

Study Chair:	Brenda Hoffman, M.D.	Medical University of South Carolina
Principal Investigator:	Eric S Edell, M.D.	Mayo Clinic, Rochester, MN
Principal Investigator:	Michael Wallace, M.D.	Mayo Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eric S. Edell, M.D., Mayo Clinic, Rochester
ClinicalTrials.gov Identifier:	NCT00970645 History of Changes
Other Study ID Numbers:	09-002240; DOD protocol A-12345.8
First Posted:	September 2, 2009
Last Update Posted:	July 18, 2011
Last Verified:	July 2011

Keywords provided by Mayo Clinic:

Non small cell lung cancer; mediastinum; endobronchial ultrasound fine needle aspiration; endoscopic ultrasound	mediastinoscopy; surgical or minimally invasive evaluation of mediastinum; NSCLC

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site	Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms