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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432640
• Other study ID #: 2006/461
• Status: Completed
• Phase: N/A
• First received: February 7, 2007
• Last updated: December 15, 2010
• Start date: January 2007
• Est. completion date: April 2009

Study information

• Verified date: December 2010
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Procedure:
• Endoscopic ultrasound staging
Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
• Surgical staging
Surgical staging

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Belgium	Leuven University Hospital	Leuven
Netherlands	Leidens Universitair Medisch Centrum (LUMC)	Leiden
United Kingdom	Papworth University Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Leiden University Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of mediastinal tumour invasion (T4)
Secondary	Assessment of the rate of avoided surgical procedures (arm A)
Secondary	Assessment of the negative predictive value
Secondary	Assessment of the difference in the cost for lymph node staging
Secondary	Assessment of the complication rates
Secondary	Assessment of the rate of futile thoracotomies
Secondary	Assessment of quality of life (EQ5D)			No

External Links

•   Website of the University Hospital Ghent