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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
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Radiosurgery
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ONSM Multisession Radiosurgery
Multisession Radiosurgery
Radiation: Multisession Radiosurgery
Patients will undergo multisession radiosurgery as clinical practice.
Other Name: Cyberknife (Accuray)




Primary Outcome Measures :
  1. visual function outcome [ Time Frame: 5 year ]
    pre and post treatment visual acuity and visual field will be evaluated


Secondary Outcome Measures :
  1. PFS - progression free survival [ Time Frame: 5 year ]
    Partial response: tumor reduction more than 20%. Progression disease: any increased

  2. Safety: level of toxicity [ Time Frame: 5 year ]
    Toxicity evaluated according to NCI CTCAE v3.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥ 18 years old
  • Patients with suspected optic nerve sheath meningioma (single lesion) Pain and/or neurologic deficit
  • KPS ≥ 70
  • Written consent

Exclusion Criteria:

  • Pregnancy
  • Bilateral meningioma or chiasma involved
  • Allergy to contrast medium

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): NCT02594709


Locations
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Italy
Instittuto Nazionale Neurologico Carlo Besta
Milano, Mi, Italy, 20133
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Investigators
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Principal Investigator: Laura Fariselli, MD Instittuto Nazionale Neurologico Carlo Besta
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Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT02594709    
Other Study ID Numbers: PRON-SM
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Meningioma
Nerve Sheath Neoplasms
Optic Nerve Neoplasms
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
Peripheral Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Cranial Nerve Neoplasms
Cranial Nerve Diseases
Optic Nerve Diseases
Eye Diseases