Multisession Radiosurgery in Large Meningiomas

Study Overview
=================
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.

Official Title
-----------------
Multisession Radiosurgery in Large Meningiomas

Conditions
-----------------
Intracranial Meningioma

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|Multisession radiosurgery|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial benign meningioma, radiosurgery, large meningioma, critical site, multisession radiosurgery