Brain Neoplasms Clinical Trial
— IORT_BRAINM1Official title:
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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Catalan Institute of Oncology | Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Institut Català d'Oncologia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median local progression free survival (PFS) | 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. | 12 months | |
Secondary | Median regional PFS (rPFS) | 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. | 12 months | |
Secondary | Global PFS (gPFS) | 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. | 12 months | |
Secondary | Median time to the initiation of systemic therapies | Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy) | 12 months | |
Secondary | Median overall survival (OS) | Time (in months) from surgery of brain metastases to death by any cause | 12 months | |
Secondary | Change in neurocognitive performance (compared to baseline): Minimental | Assessed by minimal mental scale examination | 6, and 12 months | |
Secondary | Change in neurocognitive performance (compared to baseline): Trail making | Assessed by trail making test | 6, and 12 months | |
Secondary | Change in neurocognitive performance (compared to baseline): Repetition | Assessed by number repetition test (forward and backward) | 6, and 12 months | |
Secondary | Change in neurocognitive performance (compared to baseline): Oral | Assessed by controlled oral word association test | 6, and 12 months | |
Secondary | Change in neurocognitive performance (compared to baseline): Semantic | Assessed by semantic word association | 6, and 12 months | |
Secondary | Quality of life (QoL) | Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20) | 6, and 12 months | |
Secondary | Radiation-related (acute / early delayed / late) neurotoxicity | Assessed by regular neurological examinations combined by serial MRI scans | 12 months |
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