Lung CancerNCT01117714
Surgical Versus Non-surgical Staging of Lung Cancer
A study testing Integrated Staging for Early Detection of Metastases in Lung Cancer in people with Lung Cancer, run by Medical University of South Carolina at 3 sites in United States.
Trial summary
About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph nodes are small glands found throughout the body that remove bacteria and foreign particles (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the laboratory for testing. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Integrated Staging for Early Detection of Metastases in Lung Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Jul 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
- Require either surgical or minimally invasive evaluation (EUS/EBUS) of the mediastinum
- Are medically fit to undergo surgery
- Possess known or suspected non-small cell carcinoma of the lung
- Have had PET/CT scan within 45 days of randomization
- Are eligible for complete mediastinal lymph node dissection at surgery if clinically indicated (determined at surgery)
Who cannot join
- Pathologically documented metastatic disease
- History of malignancy within 5 years other than (skin) basal cell carcinoma
- Bulky mediastinal lymphadenopathy defined as lymph node > 2.0 cm in short axis diameter or contralateral adenopathy or direct invasion mediastinum or great vessels (T4 disease) or have a malignant pleural effusion.
- Peripheral T1 tumors with radiographically normal mediastinum on PET/CT.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
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
About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph nodes are small glands found throughout the body that remove bacteria and foreign particles (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the laboratory for testing. Biopsy results can determine if the cancer has spread (metastases) and to determine the best treatment for a patient with lung cancer.
The purpose of this study is to develop a better way to detect lung cancer earlier before it spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine needle aspiration (FNA) to see if either is better for this purpose. Traditional medical practice is to surgically open the chest and biopsy suspicious lymph nodes (called a mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest to stage and treat lung cancer.
Read more
Volunteers for this study have been diagnosed with known or suspected lung cancer, and will receive one of two choices to determine if their cancer has spread:
- Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical procedure that allows physicians to view areas of the chest(including the heart, vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the trachea) tube is inserted followed by a small incision (cut) in the chest. A mediastinoscope is inserted through the incision to see the organs inside the mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or stage cancer. Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a very small incision in the chest wall. A thorascope is a thin, tube-like instrument with a light and lens which usually has a tool for removing tissue. This makes it possible to examine the lungs or other structures in the chest cavity, without making a large incision.
- EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes can be obtained and a small needle can be guided through the esophagus into suspicious nodes to biopsy lymph nodes in the chest. Other research studies have shown that using EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS involves the use of a small ultrasound scope that is passed through the opening of the trachea and into the airways. EBUS combined with EUS is a less invasive procedure that provides full view of the lymph nodes in the chest area.
- Conditions
- Lung Cancer
- Being tested
- Integrated Staging for Early Detection of Metastases in Lung Cancer
- Keywords
- Lung cancer, Lung neoplasm, Pulmonary cancer, Pulmonary neoplasm, Lung cancer staging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Staging for Early Detection of Metastases in Lung CancerProcedure or surgery
To determine the accuracy of EBUS/EUS-guided FNA when compared with surgical mediastinoscopy/thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| EUS/EBUS with FNA | Active comparator | EUS/EBUS staging will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. If present and accessible, at least one lymph node from each accessible station will be aspirated with a separate fine needle using routine FNA and cytological techniques. If multiple lymph nodes are present in a single station, the largest lymph node from that location will be sampled. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the staging procedures will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection. Receives: Procedure: Integrated Staging for Early Detection of Metastases in Lung Cancer |
| Surgical Mediastinoscopy | Active comparator | Within two months following CT scan, surgical mediastinoscopy will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the diagnostic method (medical or surgical) used for staging will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection. Receives: Procedure: Integrated Staging for Early Detection of Metastases in Lung Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of each arm for the staging of lung cancer
We will be testing whether or not the sensitivity of the EUS/EBUS technique for identifying malignant mediastinal lymph nodes is more than 10% worse than the sensitivity of the Mediastinoscopy technique. The primary analysis will be a direct comparison of the sensitivities of the 2 measures, where the sensitivity is defined as the number of true positive cases divided by the sum of the true positives and the false negatives, or the proportion of patients who truly have malignant mediastinal lymph nodes that test positive (i.e. via EUS/EBUS or Mediastinoscopy).
Measured: Two years
Secondary outcomes (1)
Complication rates for each of the diagnostic strategies
Complication rates associated with each of the diagnostic strategies will be determined based on complications recorded at the time of surgery and up to 30 days after surgery. These complications include morbidity and the length of stay attributed to the diagnostic method.
Measured: At 30 days or at the time of surgery, whichever is first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Accrual was poor at two other sites and manuscript was published which describing another study which accomplished the goals of this project.
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 Medical University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Gerard A Silvestri, MD, Principal investigator, Medical University of South CarolinaBrenda J Hoffman, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117714
- Sponsor's protocol ID
- A-13245.8
- Other IDs
- DOD, DOD
- Status last verified
- May 2018
- First submitted
- 25 Mar 2010
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. 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
- NCT01117714
- Acronym / sponsor ID
- A-13245.8
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Lung neoplasm, Pulmonary cancer, Pulmonary neoplasm, Lung cancer staging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual was poor at two other sites and manuscript was published which describing another study which accomplished the goals of this project.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Sep 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 May 2010 (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.
About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph nodes are small glands found throughout the body that remove bacteria and foreign particles (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the laboratory for testing. Biopsy results can determine if the cancer has spread (metastases) and to determine the best treatment for a patient with lung cancer.
The purpose of this study is to develop a better way to detect lung cancer earlier before it spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine needle aspiration (FNA) to see if either is better for this purpose. Traditional medical practice is to surgically open the chest and biopsy suspicious lymph nodes (called a mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest to stage and treat lung cancer.
Volunteers for this study have been diagnosed with known or suspected lung cancer, and will receive one of two choices to determine if their cancer has spread:
- Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical procedure that allows physicians to view areas of the chest(including the heart, vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the trachea) tube is inserted followed by a small incision (cut) in the chest. A mediastinoscope is inserted through the incision to see the organs inside the mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or stage cancer. Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a very small incision in the chest wall. A thorascope is a thin, tube-like instrument with a light and lens which usually has a tool for removing tissue. This makes it possible to examine the lungs or other structures in the chest cavity, without making a large incision.
- EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes can be obtained and a small needle can be guided through the esophagus into suspicious nodes to biopsy lymph nodes in the chest. Other research studies have shown that using EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS involves the use of a small ultrasound scope that is passed through the opening of the trachea and into the airways. EBUS combined with EUS is a less invasive procedure that provides full view of the lymph nodes in the chest area.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS/EBUS with FNA | Active comparator | Procedure: Integrated Staging for Early Detection of Metastases in Lung CancerEUS/EBUS staging will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. If present and accessible, at least one lymph node from each accessible station will be aspirated with a separate fine needle using routine FNA and cytological techniques. If multiple lymph nodes are present in a single station, the largest lymph node from that location will be sampled. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the staging procedures will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection. |
| Surgical Mediastinoscopy | Active comparator | Procedure: Integrated Staging for Early Detection of Metastases in Lung CancerWithin two months following CT scan, surgical mediastinoscopy will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the diagnostic method (medical or surgical) used for staging will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Require either surgical or minimally invasive evaluation (EUS/EBUS) of the mediastinum
- Are medically fit to undergo surgery
- Possess known or suspected non-small cell carcinoma of the lung
- Have had PET/CT scan within 45 days of randomization
- Are eligible for complete mediastinal lymph node dissection at surgery if clinically indicated (determined at surgery)
Key exclusion criteria (4 listed)
- Pathologically documented metastatic disease
- History of malignancy within 5 years other than (skin) basal cell carcinoma
- Bulky mediastinal lymphadenopathy defined as lymph node > 2.0 cm in short axis diameter or contralateral adenopathy or direct invasion mediastinum or great vessels (T4 disease) or have a malignant pleural effusion.
- Peripheral T1 tumors with radiographically normal mediastinum on PET/CT.
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 |
|---|---|---|
| Integrated Staging for Early Detection of Metastases in Lung CancerTo determine the accuracy of EBUS/EUS-guided FNA when compared with surgical mediastinoscopy/thoracoscopy | Procedure or surgery | EUS/EBUS with FNA, Surgical Mediastinoscopy |
Primary outcome
Accuracy of each arm for the staging of lung cancer
Time frame: Two years
We will be testing whether or not the sensitivity of the EUS/EBUS technique for identifying malignant mediastinal lymph nodes is more than 10% worse than the sensitivity of the Mediastinoscopy technique. The primary analysis will be a direct comparison of the sensitivities of the 2 measures, where the sensitivity is defined as the number of true positive cases divided by the sum of the true positives and the false negatives, or the proportion of patients who truly have malignant mediastinal lymph nodes that test positive (i.e. via EUS/EBUS or Mediastinoscopy).
1 secondary outcome
Complication rates for each of the diagnostic strategies
Time frame: At 30 days or at the time of surgery, whichever is first.
Results and safety
The study was stopped early (reason given: Accrual was poor at two other sites and manuscript was published which describing another study which accomplished the goals of this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
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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.
Gerard A Silvestri, MD principal investigator
Medical University of South Carolina
Brenda J Hoffman, MD principal investigator
Medical University of South Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Staging for Early Detection of Metastases in Lung Cancer in people with Lung Cancer, run by Medical University of South Carolina 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 16 May 2018. 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: Accrual was poor at two other sites and manuscript was published which describing another study which accomplished the goals of this project.). 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?
Accuracy of each arm for the staging of lung cancer (time frame: Two 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 16 May 2018.