Clinical Trial: Multisession Radiosurgery in Large Meningiomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Multisession Radiosurgery in Large Meningiomas

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 Summary:

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.


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

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Dates:
Date Received: October 7, 2016
Date Started: April 2011
Date Completion: April 2021
Last Updated: November 22, 2016
Last Verified: November 2016