Status:
RECRUITING
Intraoperative Radiotherapy in Patients With Brain Metastases
Lead Sponsor:
Parc de Salut Mar
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the deg...
Detailed Description
1. INTRODUCTION Brain metastases occur in roughly 30% of all cancer patients during their course of disease. Their incidence is believed to rise due to the aging population that develops more canc...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Karnofsky Performance Status ≥ 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 ( Central Nervous System i.e. non-CNS) tumor
- Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy)
- Adequate birth control
Exclusion
- Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively)
- Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma
- More than one brain metastasis
- Psychiatric or social condition potentially interfering with compliance
- Contraindication against anesthesia, surgery, MRI and/or contrast agents
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04847284
Start Date
May 5 2021
End Date
December 1 2025
Last Update
June 6 2025
Active Locations (1)
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1
Hospital del Mar
Barcelona, Spain, 08003