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Spots Global Cancer Trial Database for Multisession Radiosurgery in Large Meningiomas

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Trial Identification

Brief Title: Multisession Radiosurgery in Large Meningiomas

Official Title: Multisession Radiosurgery in Large Meningiomas

Study ID: NCT02974127

Interventions

Radiotherapy

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Laura Fariselli, MD

Affiliation: Fondazione IRCCS Istituto Neurologico Carlo BEsta

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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