Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer - Full Text View

Purpose

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	Intervention
Non Small Cell Lung Cancer	Procedure: Mediastinoscopy/thoracoscopy Procedure: EBUS/EUS


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ]


Enrollment:	2
Study Start Date:	February 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970645

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


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
Study First Received:	September 1, 2009
Last Updated:	July 15, 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

ClinicalTrials.gov processed this record on May 25, 2017