Cyberknife Radiosurgery for Patients With Neurinomas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 3
- Primary Endpoint
- Useful hearing preservation after single or multisession radiosurgery
Study Overview
Brief 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.
Detailed Description
Single-session radiosurgery versus multi-sessions radiosurgery for acoustic neuromas.
BACKGROUND 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 radiosurgery.
There remains some debate as to how best to manage these tumors. Historically, vestibular schwannomas have been treated with microsurgical resection.
Loss of hearing and facial nerve injury, however, are not uncommon microsurgical complications. Fractionated radiotherapy was used initially as an adjunct to microsurgery in patients who had undergone subtotal resection, and it demonstrated the overall effectiveness of radiation as a treating modality for vestibular schwannomas.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sporadic acoustic neuroma max diameter 3 cm
- •Age: ≥ 18 years old
- •Serviceable hearing (class A and B from the American Academy of Otorhinolaryngology-Head and Neck Surgery classification)
- •Written consent
Exclusion Criteria
- •Pregnancy
- •Allergy to contrast medium
- •Neurofibromatosis type 2 (NF2)
- •anacousia
Arms & Interventions
single session radiosurgery
single session radiosurgery (gold standard)
Intervention: Radiosurgery (Radiation)
multisession radiosurgery
multisession radiosurgery (3 fraction)
Intervention: Radiosurgery (Radiation)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- treatment effectiveness(4 months after treatment, then every 6 months for 2 years and then annually.)
- treatment safety of trigeminal nerve(4 months after treatment, then every 6 months for 2 years and then annually.)
- treatment safety of facial nerve(4 months after treatment, then every 6 months for 2 years and then annually.)