Clinical trial NCT02974127: Multisession Radiosurgery in Large Meningiomas
Official title: Multisession Radiosurgery in Large Meningiomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Meningioma
Keywords: intracranial benign meningioma
radiosurgery
large meningioma
critical site
multisession radiosurgery
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with large or in critical site benign intracranial meningioma diagnosis

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.

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.

Primary outcomes:
measure: Radiation-related toxicities.
timeFrame: change from baseline neurological assessment at 5 years.
measure: Local control evaluation assessed on MRI-based volumetric lesion measurements.
timeFrame: change from baseline volume lesion at 5 years
Secondary outcomes:
measure: Neurological assessment of trigeminal pain
timeFrame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
measure: Neurological assessment of trigeminal dysfunction
timeFrame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
measure: Neurological assessment of facial nerve dysfunction
timeFrame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
measure: Neurological assessment of acoustic nerve dysfunction
timeFrame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
measure: Neurological assessment of visual dysfunction
timeFrame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo BEsta
name: Laura Fariselli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.