Actively Recruiting
Intraoperative Radiotherapy in Patients With Brain Metastases
Led by Parc de Salut Mar · Updated on 2025-06-06
25
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 degree of efficacy is unknown, as well as and which is the most efficient dose. The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.
CONDITIONS
Official Title
Intraoperative Radiotherapy in Patients With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky Performance Status of 70 or higher
- Newly diagnosed cerebral or cerebellar lesion visible on MRI that can be fully removed by surgery without dural attachment
- Biopsy confirming metastasis from a cancer outside the central nervous system
- Safe distance from optic nerves, chiasm, and brainstem for radiation treatment
- Use of adequate birth control
You will not qualify if you...
- Presence of leptomeningeal spread or dural attachment
- Biopsy revealing primary CNS tumor, lymphoma, small-cell lung cancer, or germinoma
- More than one brain metastasis
- Psychiatric or social conditions that may affect study compliance
- Contraindications to anesthesia, surgery, MRI, or contrast agents
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
Research Team
P
Palmira Foro, MD, PhD
CONTACT
P
Palmira Foro, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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