Non Small Cell Lung CancerASTER3NCT02222194
The Value of Surgical Mediastinal Staging in Clinical N1 Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Johnny Moons at 10 sites in 6 countries.
Trial summary
In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 105 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Aug 2014to 30 May 2017
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with operable and resectable cT1-2- selectedT3 cN1 (suspected) NSCLC. (selected T3 = intraparenchymal tumour >7cm or T3 chest wall or T3 additional nodule, excluding mediastinal invasion or invasion of the main bronchus < 2cm from the carina)
Who may be able to join
- (Suspected) NSCLC Medical operable and surgical resectable cT1, cT2 selected cT3 (i.e. intraparenchymal tumour >7cm, T3 chest wall, or T3 based on additional nodule in the lobe of the primary tumour) cN1 based on CT or PET 18 years or older Informed Consent
Who cannot join
- History of mediastinoscopy No integrated FDG PET/CT available No videomediastinoscopy available EBUS/EUS for mediastinal staging of present N1 disease cN2: mediastinal nodes enlarged on CT or Pet positive invasion of mediastinal pleura invasion of phrenic nerve invasion of parietal pericardium tumour in main bronchus less than 2cm form the main carina cT4 cM1 former therapy for lung cancer (chemotherapy, radiotherapy, surgery) technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter) pregnancy inability to consent
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Germany4 sites
ELK Berlin Chest Hospital
Berlin, 13125
Albert-Ludwigs-University Freiburg
Freiburg im Breisgau, 79106
Katholisches Klinikum Koblenz
Koblenz, 56073
Katholisches Klinikum, Thoraxchirurgie
Koblenz, 56073
Spain2 sites
Hospital Universitari Mutua Terrassa
Barcelona, 08017
Hospital Clinic; Barcelona University
Barcelona, 08036
France1 site
Aix-Marseille University & Hospitals System of Marseille (AP-HM)
Marseille, 13915
Switzerland1 site
University Hospital, Division of Thoracic Surgery
Zurich, 8091
Turkey (Türkiye)1 site
Istanbul University, Cerrahpasa Medical Faculty
Istanbul, 81080
About this study
Official title: Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR
In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected) NSCLC patients.
Read the detailed description
Few reports in the literature evaluated the final pathological stage distribution of patients with resectable and operable non-small cell lung cancer (NSCLC) with clinical stage cN1. These retrospective series demonstrated that patients with computed tomography (CT) based cN1 often had clinically occult mediastinal lymph node metastases (N2/3 disease). Hishida et al. reported that 30% of 143 patients with cN1 were diagnosed N2/3 by mediastinoscopy3. Watanabe et al. reported that 37% of 168 patients with cN1 were diagnosed N2/3 by mediastinoscopy 4. Adding FDG-positron emission tomography (PET) to CT might enable the detection of N2/3 disease among these cN1 patients, but negative PET findings do not necessarily exclude N2/3 disease. Kim et al reported that 19,2 % of 99 patients with cN1, in whom cN2 was ruled out by PET-CT scan, were found to have pathologic N2 disease at pulmonary resection with mediastinal lymph node dissection.5 In conclusion, 20-30% of patients with cN1 nodes on imaging, and normal sized FDG-negative mediastinal lymph nodes on CT and PET have malignant involvement in their mediastinal nodes.
The ACCP guidelines state that invasive preoperative mediastinal staging should be performed in these cN1 patients 6. The updated ESTS guidelines recommend mediastinal staging by echo-endoscopic or mediastinoscopy.1 Non-randomized trials suggested the potential of linear endosonography for mediastinal staging 7-9. However, the patients with cN1 disease form only a minority in these studies. A recently performed prospective ASTER 2 trial (N=100) showed a sensitivity of echo-endoscopic for mediastinal staging of 38% (ITT analysis), while the prevalence of mediastinal nodal disease was 24% (unpublished data Aster 2) 2. The conclusion made by ASTER 2 is that a negative endosonography must be followed by a VAM. However, the investigators consider such double approach not cost-effective in a setting with N2 prevalence <30%. Therefore, it seems reasonable to perform a VAM instead of an endosonography in cN1 patients, which is one of the proposed strategies in the recent ESTS guidelines.1 However, there is no prospective study to date that assessed the sensitivity, NPV and accuracy of VAM in a well-defined group of cN1 patients.
Several publications have demonstrated a lobe-specific mediastinal nodal drainage for upper versus lower lobe NSCLC. Shapiro et al conclude that in early lung cancer, including cN1 disease, lobe-specific mediastinal dissection is warranted 10. However, in this study the only patient with a positive subcarinal node, upper lobe tumour, and negative superior mediastinal nodes had positive N1 nodes. To the investigators knowledge there is no study focussing on mediastinal nodal dissemination patterns in cN1 patients.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung cancer, Surgery, Videomediastinoscopy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VAM | Patients with operable and resectable cT1-2-selected T3 cN1cM0 NSCLC undergo VAM for mediastinal lymph node staging. After VAM, patients without tissue proof of N2/3 disease at surgical staging undergo a VATS or thoracotomy with systematic lymph node dissection during the same anaesthesia or at a later stage. Sensitivity, NPV and accuracy of staging with VAM will be calculated. Provided N2 lymph node metastases are proven by VAM the patient goes off study protocol and can further be assessed/treated according to local clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of VAM
Sensitivity (%) of surgical mediastinal staging by video-assisted mediastinoscopy in clinical N1; true positives (TP) = cN1 and pN1 - false negatives (FP) = cN1 and pN2/3; sensitivity is calculated as TP / (TP+FN)
Measured: at surgery (VAM)
Secondary outcomes (1)
Prevalence of N2/3 disease after VAM
% of patients with cN1 disease who show pN2/3 disease after VAM
Measured: at surgery (VAM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnny Moons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johnny Moons, University Hospital, Gasthuisberg
- Investigators
- Herbert Decaluwé, MD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222194
- Sponsor's protocol ID
- ASTER 3
- Acronym
- ASTER3
- Status last verified
- Jul 2017
- First submitted
- 18 Aug 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Decaluwe H, Dooms C, D'Journo XB, Call S, Sanchez D, Haager B, Beelen R, Kara V, Klikovits T, Aigner C, Tournoy K, Zahin M, Moons J, Brioude G, Trujillo JC, Klepetko W, Turna A, Passlick B, Molins L, Rami-Porta R, Thomas P, Leyn P. Mediastinal staging by videomediastinoscopy in clinical N1 non-small cell lung cancer: a prospective multicentre study. Eur Respir J. 2017 Dec 21;50(6):1701493. doi: 10.1183/13993003.01493-2017. Print 2017 Dec.
PubMed 29269579
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR
- ClinicalTrials.gov ID
- NCT02222194
- Acronym / sponsor ID
- ASTER3 / ASTER 3
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung cancer, Surgery, Videomediastinoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Johnny MoonsUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 21 Aug 2014 (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.
In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected) NSCLC patients.
Detailed description
Few reports in the literature evaluated the final pathological stage distribution of patients with resectable and operable non-small cell lung cancer (NSCLC) with clinical stage cN1. These retrospective series demonstrated that patients with computed tomography (CT) based cN1 often had clinically occult mediastinal lymph node metastases (N2/3 disease). Hishida et al. reported that 30% of 143 patients with cN1 were diagnosed N2/3 by mediastinoscopy3. Watanabe et al. reported that 37% of 168 patients with cN1 were diagnosed N2/3 by mediastinoscopy 4. Adding FDG-positron emission tomography (PET) to CT might enable the detection of N2/3 disease among these cN1 patients, but negative PET findings do not necessarily exclude N2/3 disease. Kim et al reported that 19,2 % of 99 patients with cN1, in whom cN2 was ruled out by PET-CT scan, were found to have pathologic N2 disease at pulmonary resection with mediastinal lymph node dissection.5 In conclusion, 20-30% of patients with cN1 nodes on imaging, and normal sized FDG-negative mediastinal lymph nodes on CT and PET have malignant involvement in their mediastinal nodes.
The ACCP guidelines state that invasive preoperative mediastinal staging should be performed in these cN1 patients 6. The updated ESTS guidelines recommend mediastinal staging by echo-endoscopic or mediastinoscopy.1 Non-randomized trials suggested the potential of linear endosonography for mediastinal staging 7-9. However, the patients with cN1 disease form only a minority in these studies. A recently performed prospective ASTER 2 trial (N=100) showed a sensitivity of echo-endoscopic for mediastinal staging of 38% (ITT analysis), while the prevalence of mediastinal nodal disease was 24% (unpublished data Aster 2) 2. The conclusion made by ASTER 2 is that a negative endosonography must be followed by a VAM. However, the investigators consider such double approach not cost-effective in a setting with N2 prevalence <30%. Therefore, it seems reasonable to perform a VAM instead of an endosonography in cN1 patients, which is one of the proposed strategies in the recent ESTS guidelines.1 However, there is no prospective study to date that assessed the sensitivity, NPV and accuracy of VAM in a well-defined group of cN1 patients.
Several publications have demonstrated a lobe-specific mediastinal nodal drainage for upper versus lower lobe NSCLC. Shapiro et al conclude that in early lung cancer, including cN1 disease, lobe-specific mediastinal dissection is warranted 10. However, in this study the only patient with a positive subcarinal node, upper lobe tumour, and negative superior mediastinal nodes had positive N1 nodes. To the investigators knowledge there is no study focussing on mediastinal nodal dissemination patterns in cN1 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAM | – | –Patients with operable and resectable cT1-2-selected T3 cN1cM0 NSCLC undergo VAM for mediastinal lymph node staging. After VAM, patients without tissue proof of N2/3 disease at surgical staging undergo a VATS or thoracotomy with systematic lymph node dissection during the same anaesthesia or at a later stage. Sensitivity, NPV and accuracy of staging with VAM will be calculated. Provided N2 lymph node metastases are proven by VAM the patient goes off study protocol and can further be assessed/treated according to local clinical practice. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable and resectable cT1-2- selectedT3 cN1 (suspected) NSCLC. (selected T3 = intraparenchymal tumour >7cm or T3 chest wall or T3 additional nodule, excluding mediastinal invasion or invasion of the main bronchus < 2cm from the carina)
Key inclusion criteria (1 listed)
- (Suspected) NSCLC Medical operable and surgical resectable cT1, cT2 selected cT3 (i.e. intraparenchymal tumour >7cm, T3 chest wall, or T3 based on additional nodule in the lobe of the primary tumour) cN1 based on CT or PET 18 years or older Informed Consent
Key exclusion criteria (1 listed)
- History of mediastinoscopy No integrated FDG PET/CT available No videomediastinoscopy available EBUS/EUS for mediastinal staging of present N1 disease cN2: mediastinal nodes enlarged on CT or Pet positive invasion of mediastinal pleura invasion of phrenic nerve invasion of parietal pericardium tumour in main bronchus less than 2cm form the main carina cT4 cM1 former therapy for lung cancer (chemotherapy, radiotherapy, surgery) technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter) pregnancy inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of VAM
Time frame: at surgery (VAM)
Sensitivity (%) of surgical mediastinal staging by video-assisted mediastinoscopy in clinical N1; true positives (TP) = cN1 and pN1 - false negatives (FP) = cN1 and pN2/3; sensitivity is calculated as TP / (TP+FN)
1 secondary outcome
Prevalence of N2/3 disease after VAM
Time frame: at surgery (VAM)
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 25 Jul 2017.
- Derived from this study: PubMed 29269579Decaluwe H, Dooms C, D'Journo XB, Call S, Sanchez D, Haager B, Beelen R, Kara V, Klikovits T, Aigner C, Tournoy K, Zahin M, Moons J, Brioude G, Trujillo JC, Klepetko W, Turna A, Passlick B, Molins L, Rami-Porta R, Thomas P, Leyn P. Mediastinal staging by videomediastinoscopy in clinical N1 non-small cell lung cancer: a prospective multicentre study. Eur Respir J. 2017 Dec 21;50(6):1701493. doi: 10.1183/13993003.01493-2017. Print 2017 Dec.
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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.
Herbert Decaluwé, MD study director
Universitaire Ziekenhuizen KU Leuven
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Johnny Moons at 10 sites in 6 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 1 inclusion and 1 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Spain, Belgium, France, Switzerland and 1 more country. 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?
Sensitivity of VAM (time frame: at surgery (VAM)). 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 NCT02222194, which also lists 1 linked publication.
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 25 Jul 2017.