External ValidatIon Trial of ASTER Trial
Conditions
Stage III Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
staging, endosonography, lung cancer, stage III
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Endoscopic ultrasonography
Type: Procedure
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 95 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
Locations
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
Status: Withdrawn
Middelheim Ziekenhuis
Antwerpen, Belgium
Status: Recruiting
Contact: Danny Galdermans
Imelda ziekenhuis
Bonheiden, Belgium
Status: Recruiting
Contact: Andre Heremans
Sint-Jan Ziekenhuis Brugge
Brugge, Belgium
Status: Recruiting
Contact: Rebecca De pauw
Hopital Erasme Brussels
Brussels, Belgium
Status: Recruiting
Contact: Dimitri Leduc
Centre Hospitalier Universitaire de Charleroi
Charleroi, Belgium
Status: Recruiting
Contact: Philippe Pierard
AZ Monica
Deurne, Belgium
Status: Recruiting
Contact: Elke Vandenbroucke
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Status: Recruiting
Contact: Paul Germonprez
Jesse Ziekenhuis
Hasselt, Belgium
Status: Recruiting
Contact: Karin Pat
Univeristair Ziekenhuis Brussel
Jette, Belgium
Status: Recruiting
Contact: Tom De Keukeleire
Center Hospitalier Jolimont
La Louvière, Belgium
Status: Recruiting
Contact: Frederic Clinckart
UCL
Mont-Godinne, Belgium
Status: Withdrawn
Hopital Sainte-Elisabeth
Namur, Belgium
Status: Recruiting
Contact: Antoine Bolly
Mariaziekenhuis
Overpelt, Belgium
Status: Recruiting
Contact: Christophe Pollefliet
Heilig Hart Ziekenhuis
Roeselare, Belgium
Status: Recruiting
Contact: Ingel Demedts
Sint-Elisabeth en Sint-Jozef ziekenhuis
Turnhout, Belgium
Status: Recruiting
Contact: Peter Driesen
Sint-Augustinus ziekenhuis
Wilrijk, Belgium
Status: Recruiting
Contact: Sofie Van Grieken
UCL Saint-Luc
Woluwe, Belgium
Status: Recruiting
Contact: Thiery Pieters
Start Date
April 2011
Completion Date
July 2013
Sponsors
Universitaire Ziekenhuizen Leuven
Source
Universitaire Ziekenhuizen Leuven
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page