Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study)
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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 |
- 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)
- 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 |
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| 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 | |
| Principal Investigator: | Kurt Tournoy, MD, PhD | University Hospital, Ghent |
| Principal Investigator: | Jouke Annema, MD | Leidens Universitair Medisch Centrum |
More Information
Additional Information:
No publications provided by University Hospital, Ghent
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013