Clinical trial NCT01332240: External ValidatIon Trial of ASTER Trial
Official title: External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stage III Lung Cancer
Keywords: staging
endosonography
lung cancer
stage III
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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.

Primary outcomes:
measure: The number of mediastinoscopies needed to detect one additional N2/3
timeFrame: 1 month
Secondary outcomes:
measure: The number of mediastinal lymph nodes stations sampled with endosonography
timeFrame: 1 month
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Antwerpen
country: Belgium
facility: Middelheim Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda ziekenhuis
city: Brugge
country: Belgium
facility: Sint-Jan Ziekenhuis Brugge
city: Brussels
country: Belgium
facility: Hopital Erasme Brussels
city: Charleroi
country: Belgium
facility: Centre Hospitalier Universitaire de Charleroi
city: Deurne
country: Belgium
facility: AZ Monica
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Hasselt
country: Belgium
facility: Jesse Ziekenhuis
city: Jette
country: Belgium
facility: Univeristair Ziekenhuis Brussel
city: La Louvière
country: Belgium
facility: Center Hospitalier Jolimont
city: Mont-Godinne
country: Belgium
facility: UCL
city: Namur
country: Belgium
facility: Hopital Sainte-Elisabeth
city: Overpelt
country: Belgium
facility: Mariaziekenhuis
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Turnhout
country: Belgium
facility: Sint-Elisabeth en Sint-Jozef ziekenhuis
city: Wilrijk
country: Belgium
facility: Sint-Augustinus ziekenhuis
city: Woluwe
country: Belgium
facility: UCL Saint-Luc
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Christophe Dooms
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ghent Belgium
name: Kurt Tournoy
role: PRINCIPAL_INVESTIGATOR
References: