Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study) - Full Text View

Purpose

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.

Condition	Intervention
Carcinoma, Non-Small-Cell Lung	Procedure: Endoscopic ultrasound staging Procedure: Surgical staging


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy Lung Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

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 Outcome Measures:

Assessment of mediastinal tumour invasion (T4)
Assessment of the rate of avoided surgical procedures (arm A)
Assessment of the negative predictive value
Assessment of the difference in the cost for lymph node staging
Assessment of the complication rates
Assessment of the rate of futile thoracotomies
Assessment of quality of life (EQ5D) [ Designated as safety issue: No ]


Enrollment:	240
Study Start Date:	January 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Endoscopic ultrasound staging	Procedure: Endoscopic ultrasound staging Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
Active Comparator: 2 Surgical staging	Procedure: Surgical staging Surgical staging

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432640

Locations


Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Leuven University Hospital
Leuven, Belgium, 3000
Netherlands
Leidens Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
United Kingdom
Papworth University Hospital
Cambridge, United Kingdom

Sponsors and Collaborators

University Hospital, Ghent

Leiden University Medical Center

Investigators


Principal Investigator:	Kurt Tournoy, MD, PhD	University Hospital, Ghent
Principal Investigator:	Jouke Annema, MD	Leidens Universitair Medisch Centrum

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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, Veseliç 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.


Responsible Party:	Kurt Tournoy, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00432640 History of Changes
Other Study ID Numbers:	2006/461
Study First Received:	February 7, 2007
Last Updated:	December 15, 2010
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:


(suspected) Non Small Cell Lung Cancer

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms	Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015