Non Small Cell Lung CancerNCT00970645
Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
A study testing Mediastinoscopy/thoracoscopy and EBUS/EUS in people with Non Small Cell Lung Cancer, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Mediastinoscopy/thoracoscopy and EBUS/EUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425-6300
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Mediastinoscopy/thoracoscopy, EBUS/EUS
- Keywords
- Non small cell lung cancer, mediastinum, endobronchial ultrasound fine needle aspiration, endoscopic ultrasound, mediastinoscopy, surgical or minimally invasive evaluation of mediastinum, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediastinoscopy/thoracoscopyProcedure or surgery
Also called Lung biopsy
Mediastinoscopy used to detect/stage lung cancer.
EBUS/EUSProcedure or surgery
Also called Endobronchial Ultrasound, Endoscopic Ultrasound
Minimal invasive technique to stage/detect lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| traditional mediastinoscopy/thoracoscopy | Active comparator | Traditional Mediastinoscopy used to detect or stage lung cancers. Receives: Procedure: Mediastinoscopy/thoracoscopy |
| EBUS/EUS | Active comparator | Minimal invasive technique for staging/detecting lung cancer. Receives: Procedure: EBUS/EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques.
Measured: Post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Similar study published results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Investigators
- Brenda Hoffman, M.D., Study chair, Medical University of South CarolinaEric S Edell, M.D., Principal investigator, Mayo Clinic, Rochester, MNMichael Wallace, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970645
- Sponsor's protocol ID
- 09-002240
- Other IDs
- DOD protocol A-12345.8
- Status last verified
- Jul 2011
- First submitted
- 1 Sep 2009
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00970645
- Acronym / sponsor ID
- 09-002240
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Similar study published results
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional mediastinoscopy/thoracoscopy | Active comparator | Procedure: Mediastinoscopy/thoracoscopyTraditional Mediastinoscopy used to detect or stage lung cancers. |
| EBUS/EUS | Active comparator | Procedure: EBUS/EUSMinimal invasive technique for staging/detecting lung cancer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediastinoscopy/thoracoscopyAlso: Lung biopsyMediastinoscopy used to detect/stage lung cancer. | Procedure or surgery | traditional mediastinoscopy/thoracoscopy |
| EBUS/EUSAlso: Endobronchial Ultrasound, Endoscopic UltrasoundMinimal invasive technique to stage/detect lung cancer. | Procedure or surgery | EBUS/EUS |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Similar study published results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Hoffman, M.D. study chair
Medical University of South Carolina
Eric S Edell, M.D. principal investigator
Mayo Clinic, Rochester, MN
Michael Wallace, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediastinoscopy/thoracoscopy and EBUS/EUS in people with Non Small Cell Lung Cancer, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Similar study published results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.