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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Thoracic endosonography
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring invasive staging, mediastinal lymph nodes, endosonography, surgical staging, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen leuven
  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thoracic endosonography

Arm Description

Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes

Outcomes

Primary Outcome Measures

Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC

Secondary Outcome Measures

NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC

Full Information

First Posted
October 18, 2011
Last Updated
October 8, 2013
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01456429
Brief Title
Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.
Acronym
ASTER2
Official Title
Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
invasive staging, mediastinal lymph nodes, endosonography, surgical staging, lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic endosonography
Arm Type
Experimental
Arm Description
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
Intervention Type
Procedure
Intervention Name(s)
Thoracic endosonography
Other Intervention Name(s)
thoracic echo-endoscopy
Intervention Description
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
Primary Outcome Measure Information:
Title
Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Time Frame
One month
Secondary Outcome Measure Information:
Title
NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Time Frame
one month
Title
Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Dooms
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kurt Tournoy
Organizational Affiliation
Universitair Ziekenhuis Gent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25211526
Citation
Dooms C, Tournoy KG, Schuurbiers O, Decaluwe H, De Ryck F, Verhagen A, Beelen R, van der Heijden E, De Leyn P. Endosonography for mediastinal nodal staging of clinical N1 non-small cell lung cancer: a prospective multicenter study. Chest. 2015 Jan;147(1):209-215. doi: 10.1378/chest.14-0534.
Results Reference
derived

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Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.

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