Clinical trial · Interventional
Intraoperative Radiotherapy After the Resection of Brain Metastases
Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study
NCT03226483CI-TRIAL-00058895INTRAMETunknownN/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)
INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. Patients won't receive further radiation therapy of the intraoperatively treated lesion.
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 Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative radiotherapy
- description
- After neurosurgical resection and proven metastasis (frozen section) a local intraoperative radiotherapy with soft energy x-rays is applied to the resection cavity. To perform this an applicator is inserted into the situs in the tightest fit rule. The highest possible dose between 30-20 Gy is chosen depending on nearby risk structures (Optic nerve, brainstem) is prescribed. After radiotherapy the applicator is removed and the surgery will be finished in standard way.
- interventionNames
- Radiation: Intraoperative Radiotherapy
Primary outcomes (1)
- measure
- Median local progression-free-survival
- timeFrame
- 2 years
- description
- Rate of recurrence of the treated lesion in the brain
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky Performance index ≥ 50% * MRI T1 Gadolinium enhancing non-dural resectable lesion * Informed consent * Adequate birth control * Frozen section confirms metastasis * Adequate distance to optic nerve and brainstem Exclusion Criteria: * Dural lesions or meningeal carcinomatosis * Frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma * Psychiatric or social condition interfering compliance * Contraindication against anesthesia, surgery, MRI and/or Gadolinium * Pregnant or breast-feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.