Multisession Radiosurgery for Optic Nerve Sheath Meningiomas (ONSMsmSRS)
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|ClinicalTrials.gov Identifier: NCT02594709|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2015
Last Update Posted : February 21, 2021
Traditional treatment options for optic nerve sheath meningiomas (ONSM) include observation, surgery and radiotherapy, but to date none of these has become the clear treatment of choice.
The role of the radiotherapy remained uncertain because of the concern about radiation related optic neuropathy In the recent past two large series of patients treated with a fractionated stereotactic radiotherapy confirmed these positive experiences in tumour control and greatly reduced the concern about the treatment related toxicity.
Under the light of successful meningiomas treatment, radiosurgery, had proposed as a treatment option. Single session, high conformality, frame based radiosurgery systems are seldom if ever proposed as ONSMs treatment due to the known dose tolerance of the optic nerve.
The first experience in ONSMs treatment with multisession radiosurgery treatment was quite promising.
The aim of the present study is to prospectively evaluate the efficacy and safety of multisession radiosurgery in ONSMs treatment.
In order to evaluate multisession radiosurgery 50 patients will be enrolled in the present study.
All patients will be treated by using multisession radiosurgery, with 5 fractions of 5 Gy each to a total dose of 25 Gy prescribed to the 75-85% isodose line. Patients were evaluated both for tumor growth control and visual function.
|Condition or disease||Intervention/treatment||Phase|
|Optic Nerve Sheath Tumors, Benign||Radiation: Multisession Radiosurgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Radiosurgery|
|Masking:||None (Open Label)|
|Official Title:||Observational Study on Multisession Radiosurgery for Optic Nerve Sheath Meningiomas|
|Actual Study Start Date :||January 1, 2011|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: ONSM Multisession Radiosurgery
Radiation: Multisession Radiosurgery
Patients will undergo multisession radiosurgery as clinical practice.
Other Name: Cyberknife (Accuray)
- visual function outcome [ Time Frame: 5 year ]pre and post treatment visual acuity and visual field will be evaluated
- PFS - progression free survival [ Time Frame: 5 year ]Partial response: tumor reduction more than 20%. Progression disease: any increased
- Safety: level of toxicity [ Time Frame: 5 year ]Toxicity evaluated according to NCI CTCAE v3.0
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): NCT02594709
|Instittuto Nazionale Neurologico Carlo Besta|
|Milano, Mi, Italy, 20133|
|Principal Investigator:||Laura Fariselli, MD||Instittuto Nazionale Neurologico Carlo Besta|