Clinical trial · Interventional
Cyberknife Radiosurgery for Patients With Neurinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sporadic Acoustic Neuromas | — | UNRESOLVED | — |
| Useful Hearing | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- single session radiosurgery
- description
- single session radiosurgery (gold standard)
- interventionNames
- Radiation: Radiosurgery
- type
- EXPERIMENTAL
- label
- multisession radiosurgery
- description
- multisession radiosurgery (3 fraction)
- interventionNames
- Radiation: Radiosurgery
Primary outcomes (1)
- measure
- Useful hearing preservation after single or multisession radiosurgery
- timeFrame
- 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".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Sporadic acoustic neuroma max diameter 3 cm * Age: ≥ 18 years old * KPS ≥ 70 * 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
References
Publications (0)
Data not yet available