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

April 5, 2011
October 18, 2011
April 2011
April 2013   (final data collection date for primary outcome measure)
The number of mediastinoscopies needed to detect one additional N2/3 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Efficacy
Same as current
Complete list of historical versions of study NCT01332240 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
External ValidatIon Trial of ASTER Trial
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Stage III Lung Cancer
Procedure: Endoscopic ultrasonography
in order to stage the mediastinum
Experimental: Endosonography
Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging
Intervention: Procedure: Endoscopic ultrasonography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
255
July 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 95 Years
No
Contact: Christophe Dooms, MD, PhD 0032 16 34.09.49 christophe.dooms@uzleuven.be
Contact: Kurt Tournoy, MD, PhD kurt.tournoy@ugent.be
Belgium
 
NCT01332240
EVITA001
No
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Christophe Dooms Universitaire Ziekenhuizen Leuven
Principal Investigator: Kurt Tournoy University Hospital Ghent Belgium
Universitaire Ziekenhuizen Leuven
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP