External ValidatIon Trial of ASTER Trial (EVITA)

October 18, 2011 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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        • Withdrawn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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endosonography
Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging
Procedure: Endoscopic ultrasonography
in order to stage the mediastinum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of mediastinoscopies needed to detect one additional N2/3
Time Frame: 1 month
Efficacy
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of mediastinal lymph nodes stations sampled with endosonography
Time Frame: 1 month
Characteristics of nodal staging; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Christophe Dooms, Universitaire Ziekenhuizen KU Leuven
  • Principal Investigator: Kurt Tournoy, University Hospital Ghent Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

October 19, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVITA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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