Intraoperative Radiotherapy in Patients With Brain Metastases

Launched by PARC DE SALUT MAR · Apr 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called intraoperative radiotherapy (IORT) for patients with brain metastases, which are cancerous growths that have spread to the brain from other parts of the body. The goal is to find out if giving radiotherapy during surgery, at a specific dose of 20 Gy, is as effective and safe as other types of radiation therapy. This method could reduce the overall time needed for treatment and make things easier for patients.

To be eligible for this study, participants must be at least 18 years old and have a certain level of health that allows for surgery. They should have a newly diagnosed brain lesion that can be completely removed and confirmed as a metastasis from a non-brain tumor. However, patients with multiple brain metastases, certain types of tumors, or specific health conditions may not qualify. If someone joins the study, they can expect close monitoring during their surgery and treatment, and they will contribute to important research that could help future patients with similar conditions.

Gender

ALL

Eligibility criteria

• 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