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
|Condition or disease||Intervention/treatment|
|Intracranial Meningioma||Radiation: Radiotherapy|
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|
|Official Title:||Multisession Radiosurgery in Large Meningiomas|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
- Radiation: Radiotherapy
Multisession radiosurgeryOther Name: Radiosurgery
- 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
- 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
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
|Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy|
|Milan, Italy, 20133|
|Principal Investigator:||Laura Fariselli, MD||Fondazione IRCCS Istituto Neurologico Carlo BEsta|