Stage III Lung CancerEVITANCT01332240
External ValidatIon Trial of ASTER Trial
A study testing Endoscopic ultrasonography in people with Stage III Lung Cancer, run by Universitaire Ziekenhuizen KU Leuven at 18 sites in Belgium.
Trial summary
As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stage III Lung Cancer
- What is being tested?
- Endoscopic ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 18 sitesBelgium
- Study dates
- Apr 2011to Jul 2013
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients with (suspected) NSCLC in whom invasive mediastinal staging is required based on presence of ACCP group B mediastinal lymph nodes and/or FDG-PET positive (visual interpretation of FDG uptake in mediastinal nodes as present) mediastinal lymph nodes (either ACCP group B or ACCP group D) in lymph node stations 2, 4, 7, 8 or 9 (see Appendix).
- Potentially operable and resectable disease.
- Radically treated previous extrathoracic malignancies are allowed whenever the extrathoracic malignancy is considered in remission, and a primary parenchymal lung tumour is present.
- Provision of a written informed consent.
Who cannot join
- Previous cervical mediastinoscopy.
- Uncorrected coagulopathy.
- Former treatment for a lung cancer.
- Patient unable to give a written informed consent.
- Absence of a primary parenchymal lung tumour.
- Distant metastases (cM1 disease) after routine clinical work-up.
- Clinical N2/3 disease only based on suspected mediastinal lymph nodes in stations 5 or 6.
- Patients belonging to ACCP groups A and C based on CT scan.
Trial locations and contacts
18 sites in 1 country.
Kurt Tournoy, MD, PhD contact
18 sites in 1 country
Belgium18 sites, 16 recruiting
- Withdrawn
Onze Lieve Vrouw Ziekenhuis
Aalst
- Recruiting
Middelheim Ziekenhuis
Antwerp
Danny Galdermans
Danny Galdermans
- Recruiting
Imelda ziekenhuis
Bonheiden
Andre Heremans
Andre Heremans
- Recruiting
Sint-Jan Ziekenhuis Brugge
Bruges
Rebecca De pauw
Rebecca De Pauw
- Recruiting
Hopital Erasme Brussels
Brussels
Dimitri Leduc
Dimitri Leduc
- Recruiting
Centre Hospitalier Universitaire de Charleroi
Charleroi
Philippe Pierard
Philippe Pierard
- Recruiting
AZ Monica
Deurne
Elke Vandenbroucke
Elke Vandenbroucke
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem
Paul Germonprez
Paul Germonprez
- Recruiting
Jesse Ziekenhuis
Hasselt
Karin Pat
Karin Pat
- Recruiting
Univeristair Ziekenhuis Brussel
Jette
Tom De Keukeleire
Tom De Keukeleire
- Recruiting
Center Hospitalier Jolimont
La Louvière
Frederic Clinckart
Fréderic Clinckart
- Withdrawn
UCL
Mont-Godinne
- Recruiting
Hopital Sainte-Elisabeth
Namur
Antoine Bolly
Antoine Bolly
- Recruiting
Mariaziekenhuis
Overpelt
Christophe Pollefliet
Christophe Pollefliet
- Recruiting
Heilig Hart Ziekenhuis
Roeselare
Ingel Demedts
Ingel Demedts
- Recruiting
Sint-Elisabeth en Sint-Jozef ziekenhuis
Turnhout
Peter Driesen
Peter Driesen
- Recruiting
Sint-Augustinus ziekenhuis
Wilrijk
Sofie Van Grieken
Sofie Van grieken
- Recruiting
UCL Saint-Luc
Woluwe
Thiery Pieters
Thiery Pieters
About this study
Official title: External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer
As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable clinical stage III non-small cell lung cancer.
Read the detailed description
Background : The observation made by the ASTER investigators might be criticized as all procedures were performed in highly experienced centers. To date, the number of mediastinoscopies needed to detect one additional N2/3 disease in the routine clinical practice of chest physician performing endosonography for mediastinal staging is unknown. The investigators therefore seek to answer whether a negative endosonography should routinely be followed by mediastinoscopy in day to day clinical practice.
Aim : As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice.
Setting : centers in Belgium with EBUS-TBNA and/or EUS-FNA experience in at least 20 patients agreed to participate and will include their patients.
Design : Prospective national observational multicenter study. All patients with clinical N2/3 disease based on CT and/or PET requiring invasive mediastinal staging will primarily undergo invasive mediastinal staging with endosonography (EBUS +/- EUS). A subsequent cervical mediastinoscopy will be performed in case no mediastinal lymph node involvement was found with endosonography. Local surgeons perform these procedures according to their institutional practice. Thoracotomy with mediastinal lymph node dissection will be the gold standard for invasive mediastinal staging, in case no mediastinal lymph node metastases were found during clinical staging including endosonography and mediastinoscopy.
Patients : The study will include 255 patients, based on the calculation of 15 consecutive patients in each participating center, in order to validate the ASTER data.
Primary endpoint : The number of mediastinoscopies needed to detect one additional N2/3.
Secondary endpoints : The number of mediastinal lymph nodes stations sampled with endosonography ; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.
- Conditions
- Stage III Lung Cancer
- Being tested
- Endoscopic ultrasonography
- Keywords
- staging, endosonography, lung cancer, stage III
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasonographyProcedure or surgery
in order to stage the mediastinum
| Study group | Role | What they receive |
|---|---|---|
| Endosonography | Experimental | Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging Receives: Procedure: Endoscopic ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of mediastinoscopies needed to detect one additional N2/3
Efficacy
Measured: 1 month
Secondary outcomes (1)
The number of mediastinal lymph nodes stations sampled with endosonography
Characteristics of nodal staging; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Lung CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Dooms, Principal investigator, Universitaire Ziekenhuizen KU LeuvenKurt Tournoy, Principal investigator, University Hospital Ghent Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332240
- Sponsor's protocol ID
- EVITA001
- Acronym
- EVITA
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer
- ClinicalTrials.gov ID
- NCT01332240
- Acronym / sponsor ID
- EVITA / EVITA001
- Conditions
- Stage III Lung Cancer
- Keywords
- staging, endosonography, lung cancer, stage III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 11 Apr 2011 (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.
As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable clinical stage III non-small cell lung cancer.
Detailed description
Background : The observation made by the ASTER investigators might be criticized as all procedures were performed in highly experienced centers. To date, the number of mediastinoscopies needed to detect one additional N2/3 disease in the routine clinical practice of chest physician performing endosonography for mediastinal staging is unknown. The investigators therefore seek to answer whether a negative endosonography should routinely be followed by mediastinoscopy in day to day clinical practice.
Aim : As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice.
Setting : centers in Belgium with EBUS-TBNA and/or EUS-FNA experience in at least 20 patients agreed to participate and will include their patients.
Design : Prospective national observational multicenter study. All patients with clinical N2/3 disease based on CT and/or PET requiring invasive mediastinal staging will primarily undergo invasive mediastinal staging with endosonography (EBUS +/- EUS). A subsequent cervical mediastinoscopy will be performed in case no mediastinal lymph node involvement was found with endosonography. Local surgeons perform these procedures according to their institutional practice. Thoracotomy with mediastinal lymph node dissection will be the gold standard for invasive mediastinal staging, in case no mediastinal lymph node metastases were found during clinical staging including endosonography and mediastinoscopy.
Patients : The study will include 255 patients, based on the calculation of 15 consecutive patients in each participating center, in order to validate the ASTER data.
Primary endpoint : The number of mediastinoscopies needed to detect one additional N2/3.
Secondary endpoints : The number of mediastinal lymph nodes stations sampled with endosonography ; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endosonography | Experimental | Procedure: Endoscopic ultrasonographyEndoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consecutive patients with (suspected) NSCLC in whom invasive mediastinal staging is required based on presence of ACCP group B mediastinal lymph nodes and/or FDG-PET positive (visual interpretation of FDG uptake in mediastinal nodes as present) mediastinal lymph nodes (either ACCP group B or ACCP group D) in lymph node stations 2, 4, 7, 8 or 9 (see Appendix).
- Potentially operable and resectable disease.
- Radically treated previous extrathoracic malignancies are allowed whenever the extrathoracic malignancy is considered in remission, and a primary parenchymal lung tumour is present.
- Provision of a written informed consent.
Key exclusion criteria (8 listed)
- Previous cervical mediastinoscopy.
- Uncorrected coagulopathy.
- Former treatment for a lung cancer.
- Patient unable to give a written informed consent.
- Absence of a primary parenchymal lung tumour.
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 |
|---|---|---|
| Endoscopic ultrasonographyin order to stage the mediastinum | Procedure or surgery | Endosonography |
Primary outcome
The number of mediastinoscopies needed to detect one additional N2/3
Time frame: 1 month
Efficacy
1 secondary outcome
The number of mediastinal lymph nodes stations sampled with endosonography
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
Kurt Tournoy, MD, PhD contact
Christophe Dooms principal investigator
Universitaire Ziekenhuizen KU Leuven
Kurt Tournoy principal investigator
University Hospital Ghent Belgium
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasonography in people with Stage III Lung Cancer, run by Universitaire Ziekenhuizen KU Leuven at 18 sites in Belgium.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Dooms, MD, PhD (0032 16 34.09.49, christophe.dooms@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of mediastinoscopies needed to detect one additional N2/3 (time frame: 1 month). 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 19 Oct 2011.