IORT After Surgical Resection of Brain Metastases

IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial

To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse

Inclusion Criteria:

• Age ≥ 18 years, Karnofsky Performance Index ≥ 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 (i.e. non-CNS) tumor.
• Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).
• Adequate birth control.
• Informed consent.

Exclusion Criteria:

• Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).
• Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.
• Psychiatric or social condition potentially interfering with compliance.
• Contraindication against anesthesia, surgery, MRI and/or contrast agents.
• Pregnant or breast-feeding women.