Omitting mediastinoscopy improves cost-effectiveness and cost-utility of NSCLC staging, despite a slightly lower metastatic nodal detection rate.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: unforeseen N2 rate.
Secondary outcome
Secondary: a) health care utilization and costs; b) composite outcome of major
morbidity plus 30-day mortality; c) overall and disease-free survival; d)
disease-specific and generic quality of life.
Background summary
Non-small cell lung cancer (NSCLC) patients with increased risk of mediastinal
lymph node metastases (N2-3) should undergo mediastinoscopy to rule out
mediastinal nodal spread, despite negative endobronchial and/or endoscopic
ultrasound (EBUS/EUS). It is unknown whether additional mediastinoscopy can be
omitted without compromising important outcomes.
Study objective
Omitting mediastinoscopy improves cost-effectiveness and cost-utility of NSCLC
staging, despite a slightly lower metastatic nodal detection rate.
Study design
Randomized trial comparing mediastinal staging strategies with and without
mediastinoscopy.
Intervention
Usually mediastinoscopy will be performed first. Patients without metastatic
nodal spread will undergo subsequent anatomic resection of the primary tumour
and mediastinal lymph node dissection. The intervention will be that patients
will directly undergo anatomic resection of the primary lung tumour including
surgical mediastinal lymph node dissection, without mediastinoscopy first.
Study burden and risks
Patients who will be randomized to the intervention, will not undergo
mediastinoscopy, thereby not exposing them to risks related to this surgery
(0.2% mortality, 5.2% major morbidity). On the other hand, some patients (about
9%) randomized to the intervention arm will undergo anatomic resection of the
primary tumour despite having N2 disease. Surgical risks are low (2.1%
mortality, 12.2% major morbidity) and almost all those patients will have
minimal N2 disease with survival rates comparable to patients with N1 disease.
All study participants will be followed up according to standard follow up
schedules, although with additional questionnaires at 5 points in time.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60692.015.17 |
| OMON | NL-OMON21273 |