Clinical trial NCT00432640: Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study)
Official title: Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: (suspected) Non Small Cell Lung Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2007-02-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Lung cancer is one of the most prevalent cancers and has a very high mortality. Both treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a field that undergoes a fast technological development. Transesophageal ultrasound guided fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques which together allow cytological analysis of all mediastinal lymph nodes. This means that the combination of both techniques enables a complete (bilateral) mediastinal investigation (N2 and N3, except para-aortal station 6).

Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally advanced disease compared to surgical staging (current standard of care).

Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in which patients are randomly assigned to either surgical staging (arm B) or endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).

Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient one session setting under conscious sedation and take together about 30 to 60 minutes. If no metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation). For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed before the EBUS-TBNA.

Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy, thorascopic mediastinal exploration or exploratory thoracotomy, performed according to institutional practice.

Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic lymph node sampling to obtain an accurate intraoperative mediastinal staging.

Primary outcome: The assessment of N2-N3 lymph node metastases.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients with NSCLC or with a clinical suspicion for lung cancer in whom mediastinal lymph node invasion (either N2 or N3) is suspected based on the available thoracic imaging
* Pending the results of the mediastinal staging, the patient is otherwise considered a candidate for a surgical treatment with the intention to cure (this is a resectable tumor)
* The patient is clinically fit for diagnostic surgery (this is an operable patient)
* No distant metastasis after routine clinical work up
* Provision of a written informed consent

Exclusion Criteria:

* Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
* Reasons because of which the patient is unable to swallow the EUS-instrument (e.g. Zenker Divertikel, unexplained esophageal stenosis) or because of which the patient is unable to undergo a bronchoscopy
* Patients who, based on available thoracic imaging, are unlikely to be staged accurately by any surgical staging procedure (mediastinoscopy/ - tomy, VATS)
* Respiratory insufficiency or other contra-indications for bronchoscopy
* Concurrent other malignancies
* Uncorrected coagulopathy
* Study cannot be discussed with the patient (e.g. mental disorder)

Primary outcomes:
measure: We hypothesize that the combination of EUS and EBUS in an out-patient one-session setting is more sensitive for the detection of locally advanced disease (N2/N3) compared to surgical staging (standard of care)
Secondary outcomes:
measure: Assessment of mediastinal tumour invasion (T4)
measure: Assessment of the rate of avoided surgical procedures (arm A)
measure: Assessment of the negative predictive value
measure: Assessment of the difference in the cost for lymph node staging
measure: Assessment of the complication rates
measure: Assessment of the rate of futile thoracotomies
measure: Assessment of quality of life (EQ5D)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: Leuven University Hospital
city: Leiden
country: Netherlands
facility: Leidens Universitair Medisch Centrum (LUMC)
city: Cambridge
country: United Kingdom
facility: Papworth University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Kurt Tournoy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leidens Universitair Medisch Centrum
name: Jouke Annema, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rintoul RC, Glover MJ, Jackson C, Hughes V, Tournoy KG, Dooms C, Annema JT, Sharples LD. Cost effectiveness of endosonography versus surgical staging in potentially resectable lung cancer: a health economics analysis of the ASTER trial from a European perspective. Thorax. 2014 Jul;69(7):679-81. doi: 10.1136/thoraxjnl-2013-204374. Epub 2013 Sep 24.
citation: Annema JT, van Meerbeeck JP, Rintoul RC, Dooms C, Deschepper E, Dekkers OM, De Leyn P, Braun J, Carroll NR, Praet M, de Ryck F, Vansteenkiste J, Vermassen F, Versteegh MI, Veselic M, Nicholson AG, Rabe KF, Tournoy KG. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010 Nov 24;304(20):2245-52. doi: 10.1001/jama.2010.1705.