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

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ClinicalTrials.gov Identifier: NCT00432640
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : December 16, 2010
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by:
University Hospital, Ghent

Study Description
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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.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Procedure: Endoscopic ultrasound staging Procedure: Surgical staging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial
Study Start Date : January 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Assessment of mediastinal tumour invasion (T4)
  2. Assessment of the rate of avoided surgical procedures (arm A)
  3. Assessment of the negative predictive value
  4. Assessment of the difference in the cost for lymph node staging
  5. Assessment of the complication rates
  6. Assessment of the rate of futile thoracotomies
  7. Assessment of quality of life (EQ5D)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

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
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: December 16, 2010
Last Verified: December 2010

Keywords provided by University Hospital, Ghent:
(suspected) Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms