Cyberknife Radiosurgery for Patients With Neurinomas (ACOUNEU)
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.
|Sporadic Acoustic Neuromas Useful Hearing||Radiation: Radiosurgery||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Cyberknife Radiosurgery for Patients With Neurinomas|
- Useful hearing preservation after single or multisession radiosurgery [ Time Frame: Change in auditory function will be registered 4 months after the treatment every 6 months during the 1st to the 3rd years and then annually or until hearing will be classified as "not serviceable hearing". ]
The primary end point of this study is the spare of auditory function in patient with acoustic neuromas with 2 different radiosurgery protocols.
The auditory function will be classified according to the American Academy of Otorhinolaryngology-Head and Neck Surgery classification) Spare of the auditory function is defined as the maintenance of the patients into the classes A and B.
- treatment effectiveness [ Time Frame: 4 months after treatment, then every 6 months for 2 years and then annually. ]tumor response: it will be evaluate on MRI images. Complete response (CR) is defined as the MRI disappearance of the lesion. Partial response (PR) is defined as 20%, decrease in the volumetric size of the lesion on MRI, stable disease (SD) as no change in the size of the lesion, and progressive disease (PD) increase in any volumetric size of the lesion, confirmed at least a the following two consecutive MRI.
- treatment safety [ Time Frame: 4 months after treatment, then every 6 months for 2 years and then annually. ]The neurological toxicity (facial and trigeminal nerve especially) Trigeminal toxicity will be registered according to Barrow Neurological Institute pain intensity score (BPS), and Barrow Neurological Institute facial numbness score (BNS). Facial nerve function is graded on the House-Brackmann (H-B) scale.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2021|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
single session radiosurgery
single session radiosurgery (gold standard)
Other Name: Cyberknife (Accuray)
Experimental: multisession radiosurgery
multisession radiosurgery (3 fraction)
Other Name: Cyberknife (Accuray)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02055859
|Contact: Laura Fariselli, MD||+39022394 ext firstname.lastname@example.org|
|Istittuto Nazionale Neurologico Carlo Besta||Recruiting|
|Milano, Mi, Italy, 20133|
|Contact: Laura Fariselli, MD +39022394 ext 2157 email@example.com|
|Sub-Investigator: Marcello Marchetti, MD|
|Principal Investigator: Laura Fariselli, MD|
|Principal Investigator:||Laura Fariselli, MD||Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta|