Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.

Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456429

Acronym

ASTER2

Enrollment

100

Registered

2011-10-20

Start date

2010-01-31

Completion date

2025-12-31

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

invasive staging, mediastinal lymph nodes, endosonography, surgical staging, lung cancer

Brief summary

This is a prospective non-randomized multicenter clinical trial performing endobronchial and esophageal ultrasound for mediastinal lymph node staging of operable and resectable cT1-T2-selectedT3 cN1 cM0 NSCLC.

Detailed description

Provided no mediastinal lymph node metastases are proven by echoendoscopy, all patients will subsequently undergo surgical staging. Patients without tissue proof of mediastinal nodal disease at surgical staging will undergo a thoracotomy with systematic lymph node dissection. Provided mediastinal lymph node metastases are proven by echoendoscopy, the patient goes off study protocol and can further be assessed/treated according to local clinical practice.

Interventions

PROCEDUREThoracic endosonography

Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with operable and resectable (suspected) NSCLC * Patients with clinical N1 staging based on PET/CT * Only T1, T2, and selected T3 (i.e. intraparenchymal tumour \>7cm, chest wall, or additional nodule in the same lobe) are allowed.

Exclusion criteria

* Patients with enlarged mediastinal lymph nodes on chest CT or FDG-PET positive mediastinal lymph nodes * Patients with a central tumour staged T3 or any T4. * All stage IV patients. * Patient unable to give informed consent. * Patient previously underwent a mediastinoscopy. * Tracheal or upper airway stenosis.

Design outcomes

Primary

Measure	Time frame
Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC	One month

Secondary

Measure	Time frame
NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC	one month
Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC	one month

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026