Multisession Radiosurgery in Large Meningiomas (MuRaLM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Meningioma
• Intervention / Treatment: Radiation: Radiotherapy

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 Type: Observational
• Enrollment (Anticipated): 178

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with large or in critical site benign intracranial meningioma diagnosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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.

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Investigators: Principal Investigator: Laura Fariselli, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): June 30, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: radiosurgery; multisession radiosurgery; intracranial benign meningioma; large meningioma; critical site
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Meningioma
• Other Study ID Numbers: SRS_LM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided