Clinical trial NCT00970645: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2009-09-02
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques.
timeFrame: Post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Brenda Hoffman, M.D.
role: STUDY_CHAIR
affiliation: Mayo Clinic, Rochester, MN
name: Eric S Edell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Michael Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References: