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

This study has been terminated.
(Similar study published results)
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00970645
First received: September 1, 2009
Last updated: July 15, 2011
Last verified: July 2011

September 1, 2009
July 15, 2011
February 2010
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00970645 on ClinicalTrials.gov Archive Site
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Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Non Small Cell Lung Cancer
  • Procedure: Mediastinoscopy/thoracoscopy
    Mediastinoscopy used to detect/stage lung cancer.
    Other Name: Lung biopsy
  • Procedure: EBUS/EUS
    Minimal invasive technique to stage/detect lung cancer.
    Other Names:
    • Endobronchial Ultrasound
    • Endoscopic Ultrasound
  • Active Comparator: traditional mediastinoscopy/thoracoscopy
    Traditional Mediastinoscopy used to detect or stage lung cancers.
    Intervention: Procedure: Mediastinoscopy/thoracoscopy
  • Active Comparator: EBUS/EUS
    Minimal invasive technique for staging/detecting lung cancer.
    Intervention: Procedure: EBUS/EUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00970645
09-002240, DOD protocol A-12345.8
No
Eric S. Edell, M.D., Mayo Clinic, Rochester
Mayo Clinic
Medical University of South Carolina
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, Jacksonville, FL
Mayo Clinic
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP