Multisession Radiosurgery in Large Meningiomas

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta178 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

178

Conditions

Intracranial Meningioma

Interventions

RadiotherapyRADIATION

Multisession radiosurgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

Milan, Italy

Outcomes

Primary Outcomes

Radiation-related toxicities.

evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0

Time frame: 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

Time frame: change from baseline volume lesion at 5 years