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This is a prospective observational trial consisting of robotic multisession radiosurgery (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial meningiomas.
To date, the treatment of choice for intracranial meningiomas is surgical removal.
Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting represents an alternative or complementary viable treatment to the neurosurgery. Despite being a well-established treatment for intracranial meningiomas, SRS might be associated with significant morbidity when large volumes or critical sites are treated. Hypofractionated stereotactic radiotherapy has the potential to deliver sharply focused high doses per fraction without increasing the risk of toxicity.
The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment delivered in multisession, for large or medium size intracranial meningiomas and/or for intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area, PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment (every 6 month after treatment).
The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0 and BPN BSN House-Brackman and sensorineural internation scale assessment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Multisession radiosurgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation-related toxicities. | evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0 | change from baseline neurological assessment at 5 years. |
| Local control evaluation assessed on MRI-based volumetric lesion measurements. | Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images | change from baseline volume lesion at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological assessment of trigeminal pain | Evaluation based on BNP scale | every 6 months, up to 3 years. Afterwards, every year up to 5 years. |
| Neurological assessment of trigeminal dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with large or in critical site benign intracranial meningioma diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Laura Fariselli, MD | Fondazione IRCCS Istituto Neurologico Carlo BEsta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy | Milan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36075299 | Derived | Pinzi V, Marchetti M, Viola A, Tramacere I, Cane I, Iezzoni C, Fariselli L. Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):153-163. doi: 10.1016/j.ijrobp.2022.08.064. Epub 2022 Sep 6. | |
| 32000819 | Derived |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Evaluation based on BNS scale
| every 6 months, up to 3 years. Afterwards, every year up to 5 years. |
| Neurological assessment of facial nerve dysfunction | Evaluation based on House-Brackman scale | every 6 months, up to 3 years. Afterwards, every year up to 5 years. |
| Neurological assessment of acoustic nerve dysfunction | Evaluation based on sensorineural international scale | every 6 months, up to 3 years. Afterwards, every year up to 5 years. |
| Neurological assessment of visual dysfunction | Evaluation based on ophthalmological evaluation | every 6 months, up to 3 years. Afterwards, every year up to 5 years. |
| Pinzi V, Marchetti M, De Martin E, Cuccarini V, Tramacere I, Ghielmetti F, Fumagalli ML, Iezzoni C, Fariselli L. Multisession radiosurgery for intracranial meningioma treatment: study protocol of a single arm, monocenter, prospective trial. Radiat Oncol. 2020 Jan 30;15(1):26. doi: 10.1186/s13014-020-1478-7. |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D008919 | Investigative Techniques |