Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer. (ASTER2)

October 8, 2013 updated by: Universitaire Ziekenhuizen KU Leuven

Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.

This is a prospective non-randomized multicenter clinical trial performing endobronchial and esophageal ultrasound for mediastinal lymph node staging of operable and resectable cT1-T2-selectedT3 cN1 cM0 NSCLC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Provided no mediastinal lymph node metastases are proven by echoendoscopy, all patients will subsequently undergo surgical staging. Patients without tissue proof of mediastinal nodal disease at surgical staging will undergo a thoracotomy with systematic lymph node dissection. Provided mediastinal lymph node metastases are proven by echoendoscopy, the patient goes off study protocol and can further be assessed/treated according to local clinical practice.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
  • Netherlands
      • Nijmegen, Netherlands, 6500
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with operable and resectable (suspected) NSCLC
  • Patients with clinical N1 staging based on PET/CT
  • Only T1, T2, and selected T3 (i.e. intraparenchymal tumour >7cm, chest wall, or additional nodule in the same lobe) are allowed.

Exclusion Criteria:

  • Patients with enlarged mediastinal lymph nodes on chest CT or FDG-PET positive mediastinal lymph nodes
  • Patients with a central tumour staged T3 or any T4.
  • All stage IV patients.
  • Patient unable to give informed consent.
  • Patient previously underwent a mediastinoscopy.
  • Tracheal or upper airway stenosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thoracic endosonography
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
Procedure: Thoracic endosonography
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
Other Names:
  • thoracic echo-endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Time Frame: One month
One month

Secondary Outcome Measures

Outcome Measure
Time Frame
NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Time Frame: one month
one month
Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Christophe Dooms, Universitaire Ziekenhuizen KU Leuven
  • Principal Investigator: Kurt Tournoy, Universitair Ziekenhuis Gent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

October 10, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aster2-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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