Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediastinoscopy/thoracoscopy
EBUS/EUS
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring Non small cell lung cancer, mediastinum, endobronchial ultrasound fine needle aspiration, endoscopic ultrasound, mediastinoscopy, surgical or minimally invasive evaluation of mediastinum, NSCLC
Eligibility 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
Sites / Locations
- Mayo Clinic
- Mayo Clinic
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
traditional mediastinoscopy/thoracoscopy
EBUS/EUS
Arm Description
Traditional Mediastinoscopy used to detect or stage lung cancers.
Minimal invasive technique for staging/detecting lung cancer.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00970645
First Posted
September 1, 2009
Last Updated
July 15, 2011
Sponsor
Mayo Clinic
Collaborators
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00970645
Brief Title
Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Similar study published results
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Non small cell lung cancer, mediastinum, endobronchial ultrasound fine needle aspiration, endoscopic ultrasound, mediastinoscopy, surgical or minimally invasive evaluation of mediastinum, NSCLC
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional mediastinoscopy/thoracoscopy
Arm Type
Active Comparator
Arm Description
Traditional Mediastinoscopy used to detect or stage lung cancers.
Arm Title
EBUS/EUS
Arm Type
Active Comparator
Arm Description
Minimal invasive technique for staging/detecting lung cancer.
Intervention Type
Procedure
Intervention Name(s)
Mediastinoscopy/thoracoscopy
Other Intervention Name(s)
Lung biopsy
Intervention Description
Mediastinoscopy used to detect/stage lung cancer.
Intervention Type
Procedure
Intervention Name(s)
EBUS/EUS
Other Intervention Name(s)
Endobronchial Ultrasound, Endoscopic Ultrasound
Intervention Description
Minimal invasive technique to stage/detect lung cancer.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Hoffman, M.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eric S Edell, M.D.
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Wallace, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-6300
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
We'll reach out to this number within 24 hrs