Multisession Radiosurgery in Large Meningiomas

Intracranial Meningioma Clinical Trial

— MuRaLM  

Official title:

Multisession Radiosurgery in Large Meningiomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02974127
• Other study ID #: SRS_LM
• Status: Active, not recruiting
• Start date: August 2011
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: April 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intracranial Meningioma
• Meningioma

Intervention

Radiation:
• Radiotherapy
Multisession radiosurgery

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Neurological assessment of trigeminal pain	Evaluation based on BNP scale	every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Secondary	Neurological assessment of trigeminal dysfunction	Evaluation based on BNS scale	every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Secondary	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.
Secondary	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.
Secondary	Neurological assessment of visual dysfunction	Evaluation based on ophthalmological evaluation	every 6 months, up to 3 years. Afterwards, every year up to 5 years.