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External ValidatIon Trial of ASTER Trial

NCT ID: NCT01332240

Last Updated: 2011-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Stage III Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endosonography

Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging

Group Type EXPERIMENTAL

Endoscopic ultrasonography

Intervention Type PROCEDURE

in order to stage the mediastinum

Interventions

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Endoscopic ultrasonography

in order to stage the mediastinum

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Dooms

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Kurt Tournoy

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ghent Belgium

Locations

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Onze Lieve Vrouw Ziekenhuis

Aalst, , Belgium

Site Status WITHDRAWN

Middelheim Ziekenhuis

Antwerp, , Belgium

Site Status RECRUITING

Imelda ziekenhuis

Bonheiden, , Belgium

Site Status RECRUITING

Sint-Jan Ziekenhuis Brugge

Bruges, , Belgium

Site Status RECRUITING

Hopital Erasme Brussels

Brussels, , Belgium

Site Status RECRUITING

Centre Hospitalier Universitaire de Charleroi

Charleroi, , Belgium

Site Status RECRUITING

AZ Monica

Deurne, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status RECRUITING

Jesse Ziekenhuis

Hasselt, , Belgium

Site Status RECRUITING

Univeristair Ziekenhuis Brussel

Jette, , Belgium

Site Status RECRUITING

Center Hospitalier Jolimont

La Louvière, , Belgium

Site Status RECRUITING

UCL

Mont-Godinne, , Belgium

Site Status WITHDRAWN

Hopital Sainte-Elisabeth

Namur, , Belgium

Site Status RECRUITING

Mariaziekenhuis

Overpelt, , Belgium

Site Status RECRUITING

Heilig Hart Ziekenhuis

Roeselare, , Belgium

Site Status RECRUITING

Sint-Elisabeth en Sint-Jozef ziekenhuis

Turnhout, , Belgium

Site Status RECRUITING

Sint-Augustinus ziekenhuis

Wilrijk, , Belgium

Site Status RECRUITING

UCL Saint-Luc

Woluwe, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Christophe Dooms, MD, PhD

Role: CONTACT

[email protected]
0032 16 34.09.49

Kurt Tournoy, MD, PhD

Role: CONTACT

[email protected]

Facility Contacts

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Danny Galdermans

Role: primary

Andre Heremans

Role: primary

Rebecca De pauw

Role: primary

Dimitri Leduc

Role: primary

Philippe Pierard

Role: primary

Elke Vandenbroucke

Role: primary

Paul Germonprez

Role: primary

Karin Pat

Role: primary

Tom De Keukeleire

Role: primary

Frederic Clinckart

Role: primary

Antoine Bolly

Role: primary

Christophe Pollefliet

Role: primary

Ingel Demedts

Role: primary

Peter Driesen

Role: primary

Sofie Van Grieken

Role: primary

Thiery Pieters

Role: primary

Other Identifiers

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EVITA001

Identifier Type: -

Identifier Source: org_study_id