Status:
ACTIVE_NOT_RECRUITING
Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
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 surgic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01456429
Start Date
January 1 2010
End Date
December 1 2025
Last Update
July 15 2024
Active Locations (3)
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1
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
2
Universitaire Ziekenhuizen leuven
Leuven, Belgium, 3000
3
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500