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.
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
Last updated: 07/15/2011
NCT ID: NCT00970645
IRB Number:09-002240
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