Clinical trial · Interventional
External ValidatIon Trial of ASTER Trial
External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer
NCT01332240CI-TRIAL-00005654EVITAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable clinical stage III non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasonography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endosonography
- description
- Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging
- interventionNames
- Procedure: Endoscopic ultrasonography
Primary outcomes (1)
- measure
- The number of mediastinoscopies needed to detect one additional N2/3
- timeFrame
- 1 month
- description
- Efficacy
Secondary outcomes (1)
- measure
- The number of mediastinal lymph nodes stations sampled with endosonography
- timeFrame
- 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Consecutive patients with (suspected) NSCLC in whom invasive mediastinal staging is required based on presence of ACCP group B mediastinal lymph nodes and/or FDG-PET positive (visual interpretation of FDG uptake in mediastinal nodes as present) mediastinal lymph nodes (either ACCP group B or ACCP group D) in lymph node stations 2, 4, 7, 8 or 9 (see Appendix). * Potentially operable and resectable disease. * Radically treated previous extrathoracic malignancies are allowed whenever the extrathoracic malignancy is considered in remission, and a primary parenchymal lung tumour is present. * Provision of a written informed consent. Exclusion Criteria: * Previous cervical mediastinoscopy. * Uncorrected coagulopathy. * Former treatment for a lung cancer. * Patient unable to give a written informed consent. * Absence of a primary parenchymal lung tumour. * Distant metastases (cM1 disease) after routine clinical work-up. * Clinical N2/3 disease only based on suspected mediastinal lymph nodes in stations 5 or 6. * Patients belonging to ACCP groups A and C based on CT scan.
References
Publications (0)
Data not yet available
No reference posted for this study.