Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Sponsor||Universitaire Ziekenhuizen Leuven|
|Start date||January 2010|
|End date||October 2013|
|Trial size||100 participants|
|Trial identifier||NCT01456429, Aster2-2010|
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|
|Gent, Belgium||Universitair Ziekenhuis Gent||no longer recruiting|
|Leuven, Belgium||Universitaire Ziekenhuizen leuven||no longer recruiting|
|Nijmegen, Netherlands||Radboud University Nijmegen Medical Centre||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
time frame: One month
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
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.
|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.|
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