Clinical trial NCT01456429: Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.
Official title: Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: invasive staging
mediastinal lymph nodes
endosonography
surgical staging
lung cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 cM0 NSCLC.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
timeFrame: One month
Secondary outcomes:
measure: NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
timeFrame: one month
measure: Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC
timeFrame: one month
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen leuven
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Christophe Dooms
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Gent
name: Kurt Tournoy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dooms C, Tournoy KG, Schuurbiers O, Decaluwe H, De Ryck F, Verhagen A, Beelen R, van der Heijden E, De Leyn P. Endosonography for mediastinal nodal staging of clinical N1 non-small cell lung cancer: a prospective multicenter study. Chest. 2015 Jan;147(1):209-215. doi: 10.1378/chest.14-0534.