IORT After Surgical Resection of Brain Metastases
- Conditions
- Brain Neoplasms
- Interventions
- Radiation: Intraoperative Radiotherapy (IORT)Procedure: Brain surgery
- Registration Number
- NCT05084092
- Lead Sponsor
- Institut Català d'Oncologia
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intraoperative Radiotherapy (IORT) Brain surgery Intraoperative Radiotherapy (IORT) administered during surgery Intraoperative Radiotherapy (IORT) Intraoperative Radiotherapy (IORT) Intraoperative Radiotherapy (IORT) administered during surgery
- Primary Outcome Measures
Name Time Method Median local progression free survival (PFS) 12 months Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.
- Secondary Outcome Measures
Name Time Method Median regional PFS (rPFS) 12 months The time (in months) from surgery to any progression outside of the 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.
Change in neurocognitive performance (compared to baseline): Repetition 6, and 12 months Assessed by number repetition test (forward and backward)
Radiation-related (acute / early delayed / late) neurotoxicity 12 months Assessed by regular neurological examinations combined by serial MRI scans
Median time to the initiation of systemic therapies 12 months Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy)
Change in neurocognitive performance (compared to baseline): Minimental 6, and 12 months Assessed by minimal mental scale examination
Global PFS (gPFS) 12 months Time (in months) from surgery to any intra- and extracranial tumor progression evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.
Change in neurocognitive performance (compared to baseline): Semantic 6, and 12 months Assessed by semantic word association
Median overall survival (OS) 12 months Time (in months) from surgery of brain metastases to death by any cause
Quality of life (QoL) 6, and 12 months Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Change in neurocognitive performance (compared to baseline): Trail making 6, and 12 months Assessed by trail making test
Change in neurocognitive performance (compared to baseline): Oral 6, and 12 months Assessed by controlled oral word association test
Trial Locations
- Locations (1)
Catalan Institute of Oncology
🇪🇸Hospitalet de Llobregat, Barcelona, Spain