Multisession Radiosurgery in Large Meningiomas

NCT ID: NCT02974127

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2021-04-30

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.

Conditions

Intracranial Meningioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Radiotherapy

Multisession radiosurgery

Intervention Type: RADIATION

Other Intervention Names

Radiosurgery

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Fariselli, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Neurologico Carlo BEsta

Locations

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

Milan, , Italy

Countries

Italy

References

Pinzi V, Marchetti M, Viola A, Tramacere I, Cane I, Iezzoni C, Fariselli L. Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):153-163. doi: 10.1016/j.ijrobp.2022.08.064. Epub 2022 Sep 6.

Reference Type: DERIVED

PMID: 36075299 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32000819 (View on PubMed)

Other Identifiers

SRS_LM

Identifier Type: -

Identifier Source: org_study_id