Intracranial Meningioma
Conditions
Keywords
intracranial benign meningioma, radiosurgery, large meningioma, critical site, multisession radiosurgery
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONRadiotherapy
Multisession radiosurgery
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* either histologically confirmed or imaging-defined benign meningioma diagnosis; * large or medium lesion size and/or in critical area (e.i. perichiasmatic area); * signed specific informed consent; * age ≥ 18 years; * for female patients, execution of pregnancy blood test; * Karnofsky Performance Status (KPS) ≥ 70.
Exclusion criteria
* histologically confirmed diagnosis of atypical or malignant meningiomas; * patients who had received prior radiotherapy in the same site; * pregnancy; * allergy for contrast medium; * neurofibromatosis diagnosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation-related toxicities. | change from baseline neurological assessment at 5 years. | evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0 |
| Local control evaluation assessed on MRI-based volumetric lesion measurements. | change from baseline volume lesion at 5 years | Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological assessment of trigeminal pain | every 6 months, up to 3 years. Afterwards, every year up to 5 years. | Evaluation based on BNP scale |
| Neurological assessment of trigeminal dysfunction | every 6 months, up to 3 years. Afterwards, every year up to 5 years. | Evaluation based on BNS scale |
| Neurological assessment of facial nerve dysfunction | every 6 months, up to 3 years. Afterwards, every year up to 5 years. | Evaluation based on House-Brackman scale |
| Neurological assessment of acoustic nerve dysfunction | every 6 months, up to 3 years. Afterwards, every year up to 5 years. | Evaluation based on sensorineural international scale |
| Neurological assessment of visual dysfunction | every 6 months, up to 3 years. Afterwards, every year up to 5 years. | Evaluation based on ophthalmological evaluation |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORLaura Fariselli, MD
Fondazione IRCCS Istituto Neurologico Carlo BEsta
Outcome results
None listed