Clinical trial · Interventional
IORT After Surgical Resection of Brain Metastases
IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial
NCT05084092CI-TRIAL-00060106IORT_BRAINM1unknownPhase 2ClinicalTrials.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)
To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse
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 |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain surgery | Procedure | — | UNRESOLVED |
| Intraoperative Radiotherapy (IORT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Radiotherapy (IORT)
- description
- Intraoperative Radiotherapy (IORT) administered during surgery
- interventionNames
- Radiation: Intraoperative Radiotherapy (IORT)
- Procedure: Brain surgery
Primary outcomes (1)
- measure
- Median local progression free survival (PFS)
- timeFrame
- 12 months
- description
- Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.
Secondary outcomes (11)
- measure
- Median regional PFS (rPFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years, Karnofsky Performance Index ≥ 70. * Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment. * Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor. * Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy). * Adequate birth control. * Informed consent. Exclusion Criteria: * Leptomeningeal spread and dural attachment (assessed pre- and intraoperative). * Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma. * Psychiatric or social condition potentially interfering with compliance. * Contraindication against anesthesia, surgery, MRI and/or contrast agents. * Pregnant or breast-feeding women.
References
Publications (0)
Data not yet available
No reference posted for this study.