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

Sponsor

Mayo Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT00970645

Collaborator

Medical University of South Carolina (Other)

Enrollment

Locations

Arms

12.9

Duration (Months)

0.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Procedure: Mediastinoscopy/thoracoscopy Procedure: EBUS/EUS	N/A

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

Study Type:

Interventional

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 :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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: Endobronchial Ultrasound Endoscopic Ultrasound

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:

Endobronchial Ultrasound

Endoscopic Ultrasound

Outcome Measures

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. [Post operative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Medical University of South Carolina	Charleston	South Carolina	United States	29425-6300