External ValidatIon Trial of ASTER Trial

Stage III Lung Cancer Clinical Trial

— EVITA  

Official title:

External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01332240
• Other study ID #: EVITA001
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2011
• Last updated: October 18, 2011
• Start date: April 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Christophe Dooms, MD, PhD
• Phone: 0032 16 34.09.49
• Email: christophe.dooms[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Neoplasms
• Stage III Lung Cancer

Intervention

Procedure:
• Endoscopic ultrasonography
in order to stage the mediastinum

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Belgium	Middelheim Ziekenhuis	Antwerpen
Belgium	Imelda ziekenhuis	Bonheiden
Belgium	Sint-Jan Ziekenhuis Brugge	Brugge
Belgium	Hopital Erasme Brussels	Brussels
Belgium	Centre Hospitalier Universitaire de Charleroi	Charleroi
Belgium	AZ Monica	Deurne
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Jesse Ziekenhuis	Hasselt
Belgium	Univeristair Ziekenhuis Brussel	Jette
Belgium	Center Hospitalier Jolimont	La Louvière
Belgium	UCL	Mont-Godinne
Belgium	Hopital Sainte-Elisabeth	Namur
Belgium	Mariaziekenhuis	Overpelt
Belgium	Heilig Hart Ziekenhuis	Roeselare
Belgium	Sint-Elisabeth en Sint-Jozef ziekenhuis	Turnhout
Belgium	Sint-Augustinus ziekenhuis	Wilrijk
Belgium	UCL Saint-Luc	Woluwe

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of mediastinoscopies needed to detect one additional N2/3	Efficacy	1 month	No
Secondary	The number of mediastinal lymph nodes stations sampled with endosonography	Characteristics of nodal staging; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.	1 month	No