MEDIASTINAL STAGING OF NON SMALL CELL LUNG CANCER BY ENDOBRONCHIAL AND ENDOSCOPIC ULTRASONOGRAPHY WITH OR WITHOUT ADDITIONAL SURGICAL MEDIASTINOSCOPY (MEDIASTrial)

Completed

• Conditions: lung cancer; non-small cell lung cancer; 10029107

• Registration Number: NL-OMON52981
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-01
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 356

Inclusion Criteria

Patients with (suspected) NSCLC without distant metastases and suspected
metastatic nodal spread on PET or CT scan; or a non PET-avid or centrally
located tumour or a peripheral tumour >3 centimeters diameter. Previous
EBUS/EUS has shown negative biopsy results.

Exclusion Criteria

Not eligible are patients with: a) highly suspected bulky mediastinal nodal
disease; b) high suspicion of single level N2-3 metastasis defined by specific
PET and EBUS/EUS characteristics; c) suspected non-resectable N2 disease; d)
insufficient comprehension of the dutch language.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: unforeseen N2 rate. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: a) health care utilization and costs; b) composite outcome of major<br /><br>morbidity plus 30-day mortality; c) overall and disease-free survival; d)<br /><br>disease-specific and generic quality of life.</p><br>