Status:
COMPLETED
Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study)
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
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 me...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00432640
Start Date
January 1 2007
End Date
April 1 2009
Last Update
December 16 2010
Active Locations (4)
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1
University Hospital Ghent
Ghent, Belgium, 9000
2
Leuven University Hospital
Leuven, Belgium, 3000
3
Leidens Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
4
Papworth University Hospital
Cambridge, United Kingdom