Intraoperative Radiotherapy in Patients With Brain Metastases

Recruiting now · Not applicable

Conditions studied: Brain Metastases

In brief

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.

Key facts

Study ID: NCT04847284
Run by: Parc de Salut Mar
People needed: 25
Starts: 2021-05-05
Expected to finish: 2025-12-01
Last updated by the study team: 2025-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Hospital del Mar — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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