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NCT Number: NCT01456429

Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Gent, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracic endosonography

Procedure

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

Other names: thoracic echo-endoscopy

Primary outcomes

  1. Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC

    Time frame: One month

Secondary outcomes

  1. NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC

    Time frame: one month

  2. Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ASTER2

Important dates

Study start
2010
Primary completion
2025
Study completion
2025
First posted
Oct 20, 2011
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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