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Multisession Radiosurgery in Large Meningiomas (MuRaLM)

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ClinicalTrials.gov Identifier: NCT02974127
Recruitment Status : Active, not recruiting
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Condition or disease Intervention/treatment
Intracranial Meningioma Radiation: Radiotherapy

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.


Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multisession Radiosurgery in Large Meningiomas
Study Start Date : April 2011
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Radiotherapy
    Multisession radiosurgery
    Other Name: Radiosurgery


Primary Outcome Measures :
  1. Radiation-related toxicities. [ Time Frame: change from baseline neurological assessment at 5 years. ]
    evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0

  2. Local control evaluation assessed on MRI-based volumetric lesion measurements. [ Time Frame: change from baseline volume lesion at 5 years ]
    Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images


Secondary Outcome Measures :
  1. Neurological assessment of trigeminal pain [ Time Frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years. ]
    Evaluation based on BNP scale

  2. Neurological assessment of trigeminal dysfunction [ Time Frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years. ]
    Evaluation based on BNS scale

  3. Neurological assessment of facial nerve dysfunction [ Time Frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years. ]
    Evaluation based on House-Brackman scale

  4. Neurological assessment of acoustic nerve dysfunction [ Time Frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years. ]
    Evaluation based on sensorineural international scale

  5. Neurological assessment of visual dysfunction [ Time Frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years. ]
    Evaluation based on ophthalmological evaluation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with large or in critical site benign intracranial meningioma diagnosis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974127


Locations
Italy
Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Investigators
Principal Investigator: Laura Fariselli, MD Fondazione IRCCS Istituto Neurologico Carlo BEsta

Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT02974127     History of Changes
Other Study ID Numbers: SRS_LM
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:
intracranial benign meningioma
radiosurgery
large meningioma
critical site
multisession radiosurgery

Additional relevant MeSH terms:
Meningioma
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