MedTrace Logo

Multisession Radiosurgery for Optic Nerve Sheath Meningiomas

NCT02594709 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-02-21

No results posted yet for this study

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.

Conditions

  • Optic Nerve Sheath Tumors, Benign

Interventions

RADIATION

Multisession Radiosurgery

Patients will undergo multisession radiosurgery as clinical practice.

Sponsors & Collaborators

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Principal Investigators

  • Laura Fariselli, MD · Instittuto Nazionale Neurologico Carlo Besta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594709 on ClinicalTrials.gov