Carcinoma, Non-Small-Cell LungNCT00432640
Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study)
A study testing Endoscopic ultrasound staging and Surgical staging in people with Carcinoma, Non-Small-Cell Lung, run by University Hospital, Ghent at 4 sites in 3 countries.
Trial summary
Lung cancer is one of the most prevalent cancers and has a very high mortality. Both treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by means of a cervical mediastinoscopy is the gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Endoscopic ultrasound staging and Surgical staging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2007to Apr 2009
- 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
- Consecutive patients with NSCLC or with a clinical suspicion for lung cancer in whom mediastinal lymph node invasion (either N2 or N3) is suspected based on the available thoracic imaging
- Pending the results of the mediastinal staging, the patient is otherwise considered a candidate for a surgical treatment with the intention to cure (this is a resectable tumor)
- The patient is clinically fit for diagnostic surgery (this is an operable patient)
- No distant metastasis after routine clinical work up
- Provision of a written informed consent
Who cannot join
- Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
- Reasons because of which the patient is unable to swallow the EUS-instrument (e.g. Zenker Divertikel, unexplained esophageal stenosis) or because of which the patient is unable to undergo a bronchoscopy
- Patients who, based on available thoracic imaging, are unlikely to be staged accurately by any surgical staging procedure (mediastinoscopy/ - tomy, VATS)
- Respiratory insufficiency or other contra-indications for bronchoscopy
- Concurrent other malignancies
- Uncorrected coagulopathy
- Study cannot be discussed with the patient (e.g. mental disorder)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Belgium2 sites
University Hospital Ghent
Ghent, 9000
Leuven University Hospital
Leuven, 3000
About this study
Official title: Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial
Lung cancer is one of the most prevalent cancers and has a very high mortality. Both treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a field that undergoes a fast technological development. Transesophageal ultrasound guided fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques which together allow cytological analysis of all mediastinal lymph nodes. This means that the combination of both techniques enables a complete (bilateral) mediastinal investigation (N2 and N3, except para-aortal station 6).
Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally advanced disease compared to surgical staging (current standard of care).
Read more
Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in which patients are randomly assigned to either surgical staging (arm B) or endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).
Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient one session setting under conscious sedation and take together about 30 to 60 minutes. If no metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation). For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed before the EBUS-TBNA.
Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy, thorascopic mediastinal exploration or exploratory thoracotomy, performed according to institutional practice.
Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic lymph node sampling to obtain an accurate intraoperative mediastinal staging.
Primary outcome: The assessment of N2-N3 lymph node metastases.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Endoscopic ultrasound staging, Surgical staging
- Keywords
- (suspected) Non Small Cell Lung Cancer
- 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.
Endoscopic ultrasound stagingProcedure or surgery
Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
Surgical stagingProcedure or surgery
Surgical staging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Endoscopic ultrasound staging Receives: Procedure: Endoscopic ultrasound staging |
| 2 | Active comparator | Surgical staging Receives: Procedure: Surgical staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
We hypothesize that the combination of EUS and EBUS in an out-patient one-session setting is more sensitive for the detection of locally advanced disease (N2/N3) compared to surgical staging (standard of care)
Secondary outcomes (7)
Assessment of mediastinal tumour invasion (T4)
Assessment of the rate of avoided surgical procedures (arm A)
Assessment of the negative predictive value
Assessment of the difference in the cost for lymph node staging
Assessment of the complication rates
Assessment of the rate of futile thoracotomies
Assessment of quality of life (EQ5D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Investigators
- Kurt Tournoy, MD, PhD, Principal investigator, University Hospital, GhentJouke Annema, MD, Principal investigator, Leidens Universitair Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432640
- Sponsor's protocol ID
- 2006/461
- Status last verified
- Dec 2010
- First submitted
- 7 Feb 2007
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rintoul RC, Glover MJ, Jackson C, Hughes V, Tournoy KG, Dooms C, Annema JT, Sharples LD. Cost effectiveness of endosonography versus surgical staging in potentially resectable lung cancer: a health economics analysis of the ASTER trial from a European perspective. Thorax. 2014 Jul;69(7):679-81. doi: 10.1136/thoraxjnl-2013-204374. Epub 2013 Sep 24.
PubMed 24064440Annema JT, van Meerbeeck JP, Rintoul RC, Dooms C, Deschepper E, Dekkers OM, De Leyn P, Braun J, Carroll NR, Praet M, de Ryck F, Vansteenkiste J, Vermassen F, Versteegh MI, Veselic M, Nicholson AG, Rabe KF, Tournoy KG. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010 Nov 24;304(20):2245-52. doi: 10.1001/jama.2010.1705.
PubMed 21098770
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00432640
- Acronym / sponsor ID
- 2006/461
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- (suspected) Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 Feb 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.
Lung cancer is one of the most prevalent cancers and has a very high mortality. Both treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a field that undergoes a fast technological development. Transesophageal ultrasound guided fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques which together allow cytological analysis of all mediastinal lymph nodes. This means that the combination of both techniques enables a complete (bilateral) mediastinal investigation (N2 and N3, except para-aortal station 6).
Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally advanced disease compared to surgical staging (current standard of care).
Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in which patients are randomly assigned to either surgical staging (arm B) or endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).
Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient one session setting under conscious sedation and take together about 30 to 60 minutes. If no metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation). For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed before the EBUS-TBNA.
Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy, thorascopic mediastinal exploration or exploratory thoracotomy, performed according to institutional practice.
Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic lymph node sampling to obtain an accurate intraoperative mediastinal staging.
Primary outcome: The assessment of N2-N3 lymph node metastases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Endoscopic ultrasound stagingEndoscopic ultrasound staging |
| 2 | Active comparator | Procedure: Surgical stagingSurgical staging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consecutive patients with NSCLC or with a clinical suspicion for lung cancer in whom mediastinal lymph node invasion (either N2 or N3) is suspected based on the available thoracic imaging
- Pending the results of the mediastinal staging, the patient is otherwise considered a candidate for a surgical treatment with the intention to cure (this is a resectable tumor)
- The patient is clinically fit for diagnostic surgery (this is an operable patient)
- No distant metastasis after routine clinical work up
- Provision of a written informed consent
Key exclusion criteria (7 listed)
- Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
- Reasons because of which the patient is unable to swallow the EUS-instrument (e.g. Zenker Divertikel, unexplained esophageal stenosis) or because of which the patient is unable to undergo a bronchoscopy
- Patients who, based on available thoracic imaging, are unlikely to be staged accurately by any surgical staging procedure (mediastinoscopy/ - tomy, VATS)
- Respiratory insufficiency or other contra-indications for bronchoscopy
- Concurrent other malignancies
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 ultrasound stagingEndoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA | Procedure or surgery | 1 |
| Surgical stagingSurgical staging | Procedure or surgery | 2 |
Primary outcome
We hypothesize that the combination of EUS and EBUS in an out-patient one-session setting is more sensitive for the detection of locally advanced disease (N2/N3) compared to surgical staging (standard of care)
7 secondary outcomes
Assessment of mediastinal tumour invasion (T4)
Assessment of the rate of avoided surgical procedures (arm A)
Assessment of the negative predictive value
Assessment of the difference in the cost for lymph node staging
Assessment of the complication rates
Assessment of the rate of futile thoracotomies
Assessment of quality of life (EQ5D)
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 16 Dec 2010.
- Derived from this study: PubMed 24064440Rintoul RC, Glover MJ, Jackson C, Hughes V, Tournoy KG, Dooms C, Annema JT, Sharples LD. Cost effectiveness of endosonography versus surgical staging in potentially resectable lung cancer: a health economics analysis of the ASTER trial from a European perspective. Thorax. 2014 Jul;69(7):679-81. doi: 10.1136/thoraxjnl-2013-204374. Epub 2013 Sep 24.
- Derived from this study: PubMed 21098770Annema JT, van Meerbeeck JP, Rintoul RC, Dooms C, Deschepper E, Dekkers OM, De Leyn P, Braun J, Carroll NR, Praet M, de Ryck F, Vansteenkiste J, Vermassen F, Versteegh MI, Veselic M, Nicholson AG, Rabe KF, Tournoy KG. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010 Nov 24;304(20):2245-52. doi: 10.1001/jama.2010.1705.
- Website of the University Hospital GhentLink 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.
Kurt Tournoy, MD, PhD principal investigator
University Hospital, Ghent
Jouke Annema, MD principal investigator
Leidens Universitair Medisch Centrum
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound staging and Surgical staging in people with Carcinoma, Non-Small-Cell Lung, run by University Hospital, Ghent at 4 sites in 3 countries.
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 7 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 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Netherlands, United Kingdom. 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?
We hypothesize that the combination of EUS and EBUS in an out-patient one-session setting is more sensitive for the detection of locally advanced disease (N2/N3) compared to surgical staging (standard of care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432640, which also lists 2 linked publications.
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 Dec 2010.