Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

External ValidatIon Trial of ASTER Trial (EVITA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01332240
First received: April 5, 2011
Last updated: October 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Stage III Lung Cancer
Procedure: Endoscopic ultrasonography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • The number of mediastinoscopies needed to detect one additional N2/3 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Efficacy


Secondary Outcome Measures:
  • The number of mediastinal lymph nodes stations sampled with endosonography [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Characteristics of nodal staging; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.


Estimated Enrollment: 255
Study Start Date: April 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endosonography
Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging
Procedure: Endoscopic ultrasonography
in order to stage the mediastinum

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332240

Contacts
Contact: Christophe Dooms, MD, PhD 0032 16 34.09.49 christophe.dooms@uzleuven.be
Contact: Kurt Tournoy, MD, PhD kurt.tournoy@ugent.be

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis Withdrawn
Aalst, Belgium
Middelheim Ziekenhuis Recruiting
Antwerpen, Belgium
Contact: Danny Galdermans         
Sub-Investigator: Danny Galdermans         
Imelda ziekenhuis Recruiting
Bonheiden, Belgium
Contact: Andre Heremans         
Sub-Investigator: Andre Heremans         
Sint-Jan Ziekenhuis Brugge Recruiting
Brugge, Belgium
Contact: Rebecca De pauw         
Sub-Investigator: Rebecca De Pauw         
Hopital Erasme Brussels Recruiting
Brussels, Belgium
Contact: Dimitri Leduc         
Sub-Investigator: Dimitri Leduc         
Centre Hospitalier Universitaire de Charleroi Recruiting
Charleroi, Belgium
Contact: Philippe Pierard         
Sub-Investigator: Philippe Pierard         
AZ Monica Recruiting
Deurne, Belgium
Contact: Elke Vandenbroucke         
Sub-Investigator: Elke Vandenbroucke         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium
Contact: Paul Germonprez         
Sub-Investigator: Paul Germonprez         
Jesse Ziekenhuis Recruiting
Hasselt, Belgium
Contact: Karin Pat         
Sub-Investigator: Karin Pat         
Univeristair Ziekenhuis Brussel Recruiting
Jette, Belgium
Contact: Tom De Keukeleire         
Sub-Investigator: Tom De Keukeleire         
Center Hospitalier Jolimont Recruiting
La Louvière, Belgium
Contact: Frederic Clinckart         
Sub-Investigator: Fréderic Clinckart         
UCL Withdrawn
Mont-Godinne, Belgium
Hopital Sainte-Elisabeth Recruiting
Namur, Belgium
Contact: Antoine Bolly         
Sub-Investigator: Antoine Bolly         
Mariaziekenhuis Recruiting
Overpelt, Belgium
Contact: Christophe Pollefliet         
Sub-Investigator: Christophe Pollefliet         
Heilig Hart Ziekenhuis Recruiting
Roeselare, Belgium
Contact: Ingel Demedts         
Sub-Investigator: Ingel Demedts         
Sint-Elisabeth en Sint-Jozef ziekenhuis Recruiting
Turnhout, Belgium
Contact: Peter Driesen         
Sub-Investigator: Peter Driesen         
Sint-Augustinus ziekenhuis Recruiting
Wilrijk, Belgium
Contact: Sofie Van Grieken         
Sub-Investigator: Sofie Van grieken         
UCL Saint-Luc Recruiting
Woluwe, Belgium
Contact: Thiery Pieters         
Sub-Investigator: Thiery Pieters         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Christophe Dooms Universitaire Ziekenhuizen Leuven
Principal Investigator: Kurt Tournoy University Hospital Ghent Belgium
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01332240     History of Changes
Other Study ID Numbers: EVITA001
Study First Received: April 5, 2011
Last Updated: October 18, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
staging
endosonography
lung cancer
stage III

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014