|- candidate number||27507|
|- NTR Number||NTR6528|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jul-2017|
|- Secondary IDs||NL60692.015.17 File Number ToetsingOnline|
|- Public Title||MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy|
|- Scientific Title||MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy|
|- hypothesis||Mediastinal staging of NSCLC by EBUS/EUS-B with and without additional cervical mediastinoscopy are both effective diagnostic strategies for assessment of mediastinal lymph node metastases. However, omitting mediastinoscopy comprises no extra waiting time until definite surgery, no additional required general anaesthesia and hospital admission, and may be associated with lower morbidity and comparable survival. Therefore, this strategy may reduce health care costs and increase quality of life.|
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC), Endosonography, Thoracic surgery , Mediastinoscopy|
|- Inclusion criteria||1. Patients underwent systematic EBUS (+ EUS-B) to evaluate mediastinal lymph nodes including tissue sampling with negative biopsy results. |
2. Patients should be fit enough to undergo resection of the primary tumour.
3. Patients should be able to undergo cervical mediastinoscopy.
4. Age of 18 years or older and able to give informed consent and fill out questionnaires.
|- Exclusion criteria||1. PET/CT demonstrates bulky N2-3 disease. |
2. The combination of a highly suspicious as well as irresectable mediastinal lymph node.
3. Non-correctable coagulopathy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-jul-2017|
|- planned closingdate||1-apr-2022|
|- Target number of participants||360|
|- Interventions||Intervention: After negative EBUS/EUS-B patients will undergo immediate anatomic resection of the primary tumour. |
Usual care: According to current national and international guidelines, patients will first undergo cervical mediastinoscopy after negative EBUS/EUS-B.
|- Primary outcome||Unforeseen N2 disease|
|- Secondary outcome||1. Hospitalization|
2. Cost-effectiveness and cost-utility
3. Morbidity: the combination of major morbidity and 30-day mortality
4. Overall 2-year survival
5. Quality of life
|- Timepoints||Baseline, 1 week after mediastinoscopy (as performed), 2 weeks, 4 weeks, 3 months, 6 months, 12 months and 24 months after start treatment.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD F.J.C. van den Broek|
|- CONTACT for SCIENTIFIC QUERIES||MD J.E. Bousema|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|ZonMw, project number: 843004109, KWF, project number 11313|
|- Brief summary||Rationale: NSCLC patients with increased risk of mediastinal lymph node metastases should undergo cervical mediastinoscopy to rule out mediastinal nodal spread, despite negative endobronchial and/or endoscopic ultrasound (EBUS/EUS-B). It is unknown whether additional mediastinoscopy can be omitted without compromising important outcomes.|
Research question: Will omitting cervical mediastinoscopy in patients with negative staging by EBUS/EUS-B be non-inferior to the strategy with additional mediastinoscopy regarding the occurrence of unforeseen N2 disease after definite surgery and be superior regarding cost-effectiveness?
Study design: Multicenter parallel randomized trial comparing two diagnostic strategies (with or without mediastinoscopy) for mediastinal staging in patients with suspected NSCLC. All randomized patients will be followed up for 2 years.
Study population: Patients are eligible for inclusion in this trial when they meet the following eligibility criteria:
1. Diagnosed (pathological proof) or suspected (based on CT and FDG-PET) with NSCLC.
2. CT and FDG-PET scan have excluded distant metastasis or an irresectable primary tumour.
3. One of the criteria defining the need for mediastinal staging are met according to the European and Dutch guidelines:
- PET/CT of the chest demonstrates CT-enlarged or FDG-PET avid hilar or mediastinal lymph nodes.
- CT demonstrates central location of the primary tumour
- FDG-PET demonstrates a PET non avid primary tumour
- Peripheral lung tumours larger than 3cm on CT
|- Main changes (audit trail)||12-okt-2017 -IK:|
Addition in exclusion criteria:
'Insufficient comprehension of the Dutch language to understand the trial information and to complete the questionnaires during follow-up period' is added.'
|- RECORD||6-jul-2017 - 14-jul-2018|