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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Radiotherapy (IORT) | Experimental | Intraoperative Radiotherapy (IORT) administered during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Radiotherapy (IORT) | Radiation | If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Global PFS (gPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miquel MaciĆ , MD | Contact | +34 93 260 77 20 | mmacia@iconcologia.net |
| Name | Affiliation | Role |
|---|---|---|
| Miquel MaciĆ , MD | Institut CatalĆ d'Oncologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalan Institute of Oncology | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Intraoperative Radiation Therapy (IORT)
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| Brain surgery | Procedure | Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy |
|
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 |
| 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 |
| Median overall survival (OS) | Time (in months) from surgery of brain metastases to death by any cause | 12 months |
| Change in neurocognitive performance (compared to baseline): Minimental | Assessed by minimal mental scale examination | 6, and 12 months |
| Change in neurocognitive performance (compared to baseline): Trail making | Assessed by trail making test | 6, and 12 months |
| Change in neurocognitive performance (compared to baseline): Repetition | Assessed by number repetition test (forward and backward) | 6, and 12 months |
| Change in neurocognitive performance (compared to baseline): Oral | Assessed by controlled oral word association test | 6, and 12 months |
| Change in neurocognitive performance (compared to baseline): Semantic | Assessed by semantic word association | 6, and 12 months |
| Quality of life (QoL) | Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20) | 6, and 12 months |
| Radiation-related (acute / early delayed / late) neurotoxicity | Assessed by regular neurological examinations combined by serial MRI scans | 12 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |