Intraoperative Radiotherapy in Patients With Brain Metastases

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 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.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

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