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

This study has been completed.
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00432640
First received: February 7, 2007
Last updated: December 15, 2010
Last verified: December 2010

February 7, 2007
December 15, 2010
January 2007
April 2009   (final data collection date for primary outcome 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)
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 mediastinoscopy (standard of care)
Complete list of historical versions of study NCT00432640 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • o assessment of the rate of futile thoracotomies
Not Provided
Not Provided
 
Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study)
Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Carcinoma, Non-Small-Cell Lung
  • Procedure: Endoscopic ultrasound staging
    Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
  • Procedure: Surgical staging
    Surgical staging
  • Experimental: 1
    Endoscopic ultrasound staging
    Intervention: Procedure: Endoscopic ultrasound staging
  • Active Comparator: 2
    Surgical staging
    Intervention: Procedure: Surgical staging

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
April 2009
April 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands,   United Kingdom
 
NCT00432640
2006/461
No
Kurt Tournoy, MD, PhD, University Hospital Ghent
University Hospital, Ghent
Leiden University Medical Center
Principal Investigator: Kurt Tournoy, MD, PhD University Hospital, Ghent
Principal Investigator: Jouke Annema, MD Leidens Universitair Medisch Centrum
University Hospital, Ghent
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP