Lung CancerNCT00559611
Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC)
A study testing Endobronchial Ultrasound and Mediastinoscopy in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare 2 different methods for checking lymph glands (in the middle of the chest) for cancer cells. Objectives: The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Endobronchial Ultrasound and Mediastinoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2007to 22 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be >/= 18 years old.
- Patient must have ECOG/Zubrod status 0, 1, or 2.
- Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, sarcomatoid, neuroendocrine or large cell) and be clinical Stage IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
- Patient must have proven or suspected NSCLC prior to registration. Patients who obtain subsequent pathologic confirmation of NSCLC at the time of EBUS or subsequent surgery will remain enrolled on the study. Patients subsequently found to have an etiology other than NSCLC will be excluded from further analysis.
- Patient must be anticipated to have definitive therapy for primary NSCLC. This may include surgery, chemotherapy, radiation therapy or a combination the above.
- Patient must be medically fit for definitive therapy.
- Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Who cannot join
- Patient has received prior chemotherapy or radiotherapy for this cancer.
- Patient is considered a poor risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
- Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: Latex allergy; Bleeding diathesis; Previous mediastinoscopy; Previous mediastinal nodal resection; Previous tracheostomy.
- Patients malignancy not consistent with NSCLC
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prospective Comparison of Endobronchial Ultrasound Needle Biopsy Versus Mediastinoscopy for Staging of Mediastinal Nodes in Patients With Clinical Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to compare 2 different methods for checking lymph glands (in the middle of the chest) for cancer cells.
Objectives:
Read more
The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the 'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung cancer.
Primary Objective:
To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases.
Secondary Objectives:
To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes (number and location of nodes biopsied, number and location of positive nodes, extracapsular extension, ability to biopsy contralateral nodes).
To determine the frequency of change of planned therapeutic management resulting from outcome of EBUS-FNA and mediastinoscopy.
To determine procedure related complications. To perform analysis of cost between EBUS-FNA and mediastinoscopy.
Read the detailed description
The current procedure used to check for cancer cells in the lungs is a small operation at the base of the neck (mediastinoscopy) to get samples of the lymph glands. These samples are then looked at under the microscope to see if they contain cancer cells. A procedure has been developed that may allow doctors to get samples of lymph glands without having to perform an operation. This is called endobronchial ultrasound or "EBUS". The purpose of this study is to compare the 2 procedures.
If you agree to take part in this study, your insurance provider will be contacted. In order for you to take part in this study, your insurance provider must agree to pay for both the EBUS and mediastinoscopy procedures.
If your insurance provider agrees to pay for both procedures, you will be scheduled for the EBUS and a mediastinoscopy. The procedures will not be scheduled on the same day. You will first have the EBUS. You will receive general anesthesia and a small flexible scope will be passed down your windpipe. Samples of your lymph gland tissue will then be collected through a tiny needle that is passed through the scope. This will be performed as an out patient procedure.
If a tumor is found on the opposite side of your chest from another tumor by the EBUS, a mediastinoscopy will not be necessary.
If a tumor is not found on the opposite side of your chest from another tumor by the EBUS, you will then have a mediastinoscopy. This is also an outpatient procedure that will involve a small (2 cm) cut at the base of the neck, just above the breast bone. Your doctor will then pass a special scope with a camera into your chest (below the breast bone). This will allow your doctor to see the lymph glands around your windpipe and get samples of them. This will also be performed under general anesthesia and you will be able to leave the hospital shortly after the procedure.
Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the best therapy for the tumor to you.
This is an investigational study. The EBUS is FDA approved. The mediastinoscopy is considered standard of care. The comparison of the 2 procedures is investigational.
Up to 100 patients will be take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Endobronchial Ultrasound, Mediastinoscopy
- Keywords
- Non-Small Lung Cancer, Lung Cancer, Endobronchial Ultrasound, Fine Needle Aspiration, Mediastinoscopy, EBUS-FNA, EBUS, Needle Biopsy, NSCLC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial UltrasoundProcedure or surgery
Also called EBUS
A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.
MediastinoscopyProcedure or surgery
Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial Ultrasound vs. Mediastinoscopy | Experimental | Endobronchial Ultrasound - A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.
Mediastinoscopy - Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS. Receives: Procedure: Endobronchial Ultrasound; Procedure: Mediastinoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation
Outcome defined as how many patients EBUS stage N0/1 actually end up being N2/3, and how many EBUS stage N2 actually are N3 by mediastinoscopy. Study primarily interested in an upper limit on this proportion. Primary analysis is the upper one-sided 90% confidence limit.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study start19 Oct 2007
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David C. Rice, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559611
- Sponsor's protocol ID
- 2007-0353
- Other IDs
- NCI-2011-01302
- Status last verified
- Mar 2018
- First submitted
- 14 Nov 2007
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Endobronchial Ultrasound Needle Biopsy Versus Mediastinoscopy for Staging of Mediastinal Nodes in Patients With Clinical Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00559611
- Acronym / sponsor ID
- 2007-0353
- Conditions
- Lung Cancer
- Keywords
- Non-Small Lung Cancer, Lung Cancer, Endobronchial Ultrasound, Fine Needle Aspiration, Mediastinoscopy, EBUS-FNA, EBUS, Needle Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Oct 2007 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 16 Nov 2007 (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.
The goal of this clinical research study is to compare 2 different methods for checking lymph glands (in the middle of the chest) for cancer cells.
Objectives:
The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the 'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung cancer.
Primary Objective:
To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases.
Secondary Objectives:
To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes (number and location of nodes biopsied, number and location of positive nodes, extracapsular extension, ability to biopsy contralateral nodes).
To determine the frequency of change of planned therapeutic management resulting from outcome of EBUS-FNA and mediastinoscopy.
To determine procedure related complications. To perform analysis of cost between EBUS-FNA and mediastinoscopy.
Detailed description
The current procedure used to check for cancer cells in the lungs is a small operation at the base of the neck (mediastinoscopy) to get samples of the lymph glands. These samples are then looked at under the microscope to see if they contain cancer cells. A procedure has been developed that may allow doctors to get samples of lymph glands without having to perform an operation. This is called endobronchial ultrasound or "EBUS". The purpose of this study is to compare the 2 procedures.
If you agree to take part in this study, your insurance provider will be contacted. In order for you to take part in this study, your insurance provider must agree to pay for both the EBUS and mediastinoscopy procedures.
If your insurance provider agrees to pay for both procedures, you will be scheduled for the EBUS and a mediastinoscopy. The procedures will not be scheduled on the same day. You will first have the EBUS. You will receive general anesthesia and a small flexible scope will be passed down your windpipe. Samples of your lymph gland tissue will then be collected through a tiny needle that is passed through the scope. This will be performed as an out patient procedure.
If a tumor is found on the opposite side of your chest from another tumor by the EBUS, a mediastinoscopy will not be necessary.
If a tumor is not found on the opposite side of your chest from another tumor by the EBUS, you will then have a mediastinoscopy. This is also an outpatient procedure that will involve a small (2 cm) cut at the base of the neck, just above the breast bone. Your doctor will then pass a special scope with a camera into your chest (below the breast bone). This will allow your doctor to see the lymph glands around your windpipe and get samples of them. This will also be performed under general anesthesia and you will be able to leave the hospital shortly after the procedure.
Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the best therapy for the tumor to you.
This is an investigational study. The EBUS is FDA approved. The mediastinoscopy is considered standard of care. The comparison of the 2 procedures is investigational.
Up to 100 patients will be take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endobronchial Ultrasound vs. Mediastinoscopy | Experimental | Procedure: Endobronchial Ultrasound, Procedure: MediastinoscopyEndobronchial Ultrasound - A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope. Mediastinoscopy - Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must be >/= 18 years old.
- Patient must have ECOG/Zubrod status 0, 1, or 2.
- Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, sarcomatoid, neuroendocrine or large cell) and be clinical Stage IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
- Patient must have proven or suspected NSCLC prior to registration. Patients who obtain subsequent pathologic confirmation of NSCLC at the time of EBUS or subsequent surgery will remain enrolled on the study. Patients subsequently found to have an etiology other than NSCLC will be excluded from further analysis.
- Patient must be anticipated to have definitive therapy for primary NSCLC. This may include surgery, chemotherapy, radiation therapy or a combination the above.
Key exclusion criteria (4 listed)
- Patient has received prior chemotherapy or radiotherapy for this cancer.
- Patient is considered a poor risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
- Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: Latex allergy; Bleeding diathesis; Previous mediastinoscopy; Previous mediastinal nodal resection; Previous tracheostomy.
- Patients malignancy not consistent with NSCLC
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 |
|---|---|---|
| Endobronchial UltrasoundAlso: EBUSA small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope. | Procedure or surgery | Endobronchial Ultrasound vs. Mediastinoscopy |
| MediastinoscopyPerformed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS. | Procedure or surgery | Endobronchial Ultrasound vs. Mediastinoscopy |
Primary outcome
Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation
Time frame: 2 Years
Outcome defined as how many patients EBUS stage N0/1 actually end up being N2/3, and how many EBUS stage N2 actually are N3 by mediastinoscopy. Study primarily interested in an upper limit on this proportion. Primary analysis is the upper one-sided 90% confidence limit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
David C. Rice, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial Ultrasound and Mediastinoscopy in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site 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 7 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation (time frame: 2 Years). 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 29 Mar 2018.