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Cyberknife Radiosurgery for Patients With Neurinomas

NCT02055859 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-02-21

No results posted yet for this study

Summary

Most vestibular schwannomas are benign and slow-growing. Based on that fact, conservative management with serial imaging is a viable alternative. For patients who undergo treatment because of tumor growth, progressive symptoms, or personal preference, options include serial observation, microsurgical resection, fractionated stereotactic radiotherapy, and stereotactic single-session radiosurgery.

Despite improved radiosurgical techniques and lower marginal doses, a recent report has shown a somewhat disappointing 10-year actuarial hearing preservation rate of 44.5%, with hearing loss developing as much as 6 years after.

Fractionation of the prescribed dose may takes some advantages from radiobiologic principles to reduce toxicity and maintain tumor control.

Staged frame-based radiotherapy using a 12-hour interfraction interval was successfully used at Stanford university and has shown a hearing preservation rate of 77% at 2 years of follow-up.

The aim of the present protocol is to evaluate the hearing preservation, the local control and toxicity after single-session (sSRS) or multi-session (3 fractions) radiosurgery (mSRS) by using the frameless robotic CyberKnife® system (Accuray Incorporated, Sunnyvale, CA, USA).

In order to investigate about this a randomised controlled double harm (sSRS vs mSRS) trial was designed.

Conditions

  • Sporadic Acoustic Neuromas
  • Useful Hearing

Interventions

RADIATION

Radiosurgery

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Laura Fariselli, MD · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-15
Primary Completion
2023-05-31
Completion
2025-05-31

Countries

  • Italy

Study Locations

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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 NCT02055859 on ClinicalTrials.gov