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

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

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.

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Mediastinoscopy/thoracoscopy; Procedure: EBUS/EUS

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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: Endoscopic Ultrasound; Endobronchial Ultrasound

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 1, 2009
• First Submitted That Met QC Criteria: September 1, 2009
• First Posted (Estimate): September 2, 2009

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: NSCLC; endoscopic ultrasound; Non small cell lung cancer; mediastinum; mediastinoscopy; endobronchial ultrasound fine needle aspiration; surgical or minimally invasive evaluation of mediastinum
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 09-002240; DOD protocol A-12345.8