Multisession Radiosurgery in Large Meningiomas

• Conditions: Intracranial Meningioma

• Registration Number: NCT02974127
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Primary Completion: 2020-06-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 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 visual dysfunction	every 6 months, up to 3 years. Afterwards, every year up to 5 years.	Evaluation based on ophthalmological evaluation
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

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy; 🇮🇹 Milan, Italy