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


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

One month

Safety Issue:

No

Principal Investigator

Christophe Dooms

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven

Authority:

Belgium: Institutional Review Board

Study ID:

Aster2-2010

NCT ID:

NCT01456429

Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • invasive staging
  • mediastinal lymph nodes
  • endosonography
  • surgical staging
  • lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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