Multisession Radiosurgery in Large Meningiomas

NCT02974127 | Unknown

• 1 other identifier: SRS_LM
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Meningioma

Keywords

intracranial benign meningioma; radiosurgery; large meningioma; critical site; multisession radiosurgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Neurological assessment of trigeminal pain

  every 6 months, up to 3 years. Afterwards, every year up to 5 years.

• Neurological assessment of trigeminal dysfunction

  every 6 months, up to 3 years. Afterwards, every year up to 5 years.

• Neurological assessment of facial nerve dysfunction

  every 6 months, up to 3 years. Afterwards, every year up to 5 years.

• Neurological assessment of acoustic nerve dysfunction

  every 6 months, up to 3 years. Afterwards, every year up to 5 years.

• Neurological assessment of visual dysfunction

  every 6 months, up to 3 years. Afterwards, every year up to 5 years.

Interventions

Radiotherapy RADIATION

Multisession radiosurgery

Also known as: Radiosurgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with large or in critical site benign intracranial meningioma diagnosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

Milan, 20133, Italy

Location

Related Publications (2)

• 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.

  PMID: 36075299 DERIVED

• 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.

  PMID: 32000819 DERIVED

MeSH Terms

Conditions

Meningioma

Interventions

Radiotherapy; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laura Fariselli, MD

  Fondazione IRCCS Istituto Neurologico Carlo BEsta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: November 28, 2016
• Study Start: August 1, 2011
• Primary Completion: June 30, 2020
• Study Completion: April 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

IT (1)