Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment thoracic endosonography
Sponsor Universitaire Ziekenhuizen Leuven
Start date January 2010
End date October 2013
Trial size 100 participants
Trial identifier NCT01456429, Aster2-2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
thoracic endosonography thoracic echo-endoscopy
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.
Principal investigator Christophe Dooms
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.