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

NCT00432640 | Completed

• 1 other identifier: 2006/461
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 4

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

(suspected) Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• 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

Study Arms (2)

1

EXPERIMENTAL

Endoscopic ultrasound staging

Procedure: Endoscopic ultrasound staging

2

ACTIVE COMPARATOR

Surgical staging

Procedure: Surgical staging

Interventions

Endoscopic ultrasound staging PROCEDURE

Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA

1

Surgical staging PROCEDURE

Surgical staging

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Leiden University Medical Center: collaborator

Study Sites (4)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Leuven University Hospital

Leuven, 3000, Belgium

Location

Leidens Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Location

Papworth University Hospital

Cambridge, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24064440 DERIVED

• 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.

  PMID: 21098770 DERIVED

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kurt Tournoy, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Jouke Annema, MD

  Leidens Universitair Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 8, 2007
• Study Start: January 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 16, 2010

Record last verified: 2010-12

Locations

GB (1); NL (1); BE (2)