Schwannoma, VestibularSchwannomasNCT07801560
CyberKnife Radiotherapy for the Treatment of Schwannomas
An observational study of Schwannoma, Vestibular, run by Hartmann Oncology Radiotherapy Group, France at 1 site in France.
Trial summary
Historically, the management of schwannomas has relied primarily on observation, surgery, or conventional radiotherapy techniques. However, while surgery is curative, it carries significant risks-including postoperative complications, neurological deficits, and substantial morbidity-particularly for intracranial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schwannoma, Vestibular
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients managed for a schwannoma at the Hartmann Radiotherapy Institute and treated with stereotactic radiotherapy .
Who may be able to join
- ≥ 18 years old
- Patients with a confirmed histopathological diagnosis of vestibular schwannoma
- Patients who received stereotactic radiosurgery (SRS) for schwannoma
- Patients with available data on clinical and radiological outcomes
Who cannot join
- Patients who received other forms of radiotherapy, surgery, or experimental treatments for the schwannoma prior to stereotactic radiotherapy
- Medical records that are incomplete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of CyberKnife Radiotherapy for the Treatment of Schwannomas: A Single-Center Retrospective Study
Historically, the management of schwannomas has relied primarily on observation, surgery, or conventional radiotherapy techniques. However, while surgery is curative, it carries significant risks-including postoperative complications, neurological deficits, and substantial morbidity-particularly for intracranial schwannomas located near critical neurovascular structures.
Stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) has emerged as a less invasive alternative, offering remarkable precision in targeting tumor tissue while sparing adjacent healthy structures. This technique employs high doses of radiation focused precisely on the tumor, thereby controlling tumor growth with minimal morbidity. Several studies have demonstrated that SRS is particularly effective for small- to medium-sized schwannomas, yielding high tumor control rates (exceeding 90% at 5 years) while preserving neurological function. Despite this, the natural history, clinical data, and post-treatment outcomes associated with schwannomas remain incompletely understood or not fully elucidated in scientific literature.
Read the detailed description
Schwannomas are benign tumors arising from Schwann cells in the peripheral nervous system; the most common type is the vestibular schwannoma (also known as an acoustic neuroma). Although these tumors are non-malignant, their location-particularly on cranial or spinal nerves-can lead to serious complications such as hearing loss, balance disorders, and neurological dysfunction. Treatment aims to prevent tumor growth and preserve neurological function.
The natural history, clinical data, and post-treatment outcomes of schwannomas remain incomplete or not fully elucidated.
Stereotactic radiosurgery (SRS) has emerged as a less invasive alternative, offering remarkable precision in targeting tumor tissue while sparing adjacent healthy structures. This technique employs high doses of radiation focused precisely on the tumor, thereby controlling tumor growth with minimal morbidity. Several studies have demonstrated that SRS is particularly effective for small- to medium-sized schwannomas, yielding high tumor control rates (exceeding 90% at 5 years) while preserving neurological function. Despite this, the natural history, clinical data, and post-treatment outcomes associated with schwannomas remain incompletely understood or not fully elucidated in scientific literature.
Real-world data enables a better understanding of diseases, the optimization of care pathways, and the acceleration of the development of new treatments or personalized diagnostics.
- Conditions
- Schwannoma, Vestibular
- Keywords
- schwnommas, vestibular schwannoma, cyberknife, neurinoma, radiotherapy
- Medical subject headings
- Neuroma, Acoustic, Neurilemmoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | Patients with vestibular schwannoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy data on stereotactic radiotherapy for the treatment of schwannomas
MRI data (comparison of initial schwannoma volume with follow-up volume)
Measured: 6 months
Secondary outcomes (3)
Side effects associated with stereotactic radiotherapy treatment
Adverse events (measured by CTCAE v5.0 criteria - Common Terminology Criteria for Adverse Events)
Measured: 6 months
Survival
6-month post-treatment survival rate
Measured: 6 months
Quality of life assessment
Quality-of-life questionnaires (EORTC-QLQ-C30). Most questions use a 4-point scale from "Not at all" to "Very much" with a one-week recall period. Raw scores are averaged and transformed into a 0-100 scale using official EORTC scoring algorithms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jan 2016
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schwannoma, VestibularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartmann Oncology Radiotherapy Group, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Rafael
- Responsible party
- Sponsor
- Investigators
- Nathaniel SCHER, M.D, Principal investigator, Hartmann Oncology Radiotherapy Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801560
- Sponsor's protocol ID
- HORG-2026-001
- Other IDs
- HORG-2026-001
- Acronym
- Schwannomas
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of CyberKnife Radiotherapy for the Treatment of Schwannomas: A Single-Center Retrospective Study
- ClinicalTrials.gov ID
- NCT07801560
- Acronym / sponsor ID
- Schwannomas / HORG-2026-001
- Conditions
- Schwannoma, Vestibular
- Keywords
- schwnommas, vestibular schwannoma, cyberknife, neurinoma, radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hartmann Oncology Radiotherapy Group, FranceUniversity, hospital or other
- Collaborators
- Institut Rafael
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Historically, the management of schwannomas has relied primarily on observation, surgery, or conventional radiotherapy techniques. However, while surgery is curative, it carries significant risks-including postoperative complications, neurological deficits, and substantial morbidity-particularly for intracranial schwannomas located near critical neurovascular structures.
Stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) has emerged as a less invasive alternative, offering remarkable precision in targeting tumor tissue while sparing adjacent healthy structures. This technique employs high doses of radiation focused precisely on the tumor, thereby controlling tumor growth with minimal morbidity. Several studies have demonstrated that SRS is particularly effective for small- to medium-sized schwannomas, yielding high tumor control rates (exceeding 90% at 5 years) while preserving neurological function. Despite this, the natural history, clinical data, and post-treatment outcomes associated with schwannomas remain incompletely understood or not fully elucidated in scientific literature.
Detailed description
Schwannomas are benign tumors arising from Schwann cells in the peripheral nervous system; the most common type is the vestibular schwannoma (also known as an acoustic neuroma). Although these tumors are non-malignant, their location-particularly on cranial or spinal nerves-can lead to serious complications such as hearing loss, balance disorders, and neurological dysfunction. Treatment aims to prevent tumor growth and preserve neurological function.
The natural history, clinical data, and post-treatment outcomes of schwannomas remain incomplete or not fully elucidated.
Stereotactic radiosurgery (SRS) has emerged as a less invasive alternative, offering remarkable precision in targeting tumor tissue while sparing adjacent healthy structures. This technique employs high doses of radiation focused precisely on the tumor, thereby controlling tumor growth with minimal morbidity. Several studies have demonstrated that SRS is particularly effective for small- to medium-sized schwannomas, yielding high tumor control rates (exceeding 90% at 5 years) while preserving neurological function. Despite this, the natural history, clinical data, and post-treatment outcomes associated with schwannomas remain incompletely understood or not fully elucidated in scientific literature.
Real-world data enables a better understanding of diseases, the optimization of care pathways, and the acceleration of the development of new treatments or personalized diagnostics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | –Patients with vestibular schwannoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients managed for a schwannoma at the Hartmann Radiotherapy Institute and treated with stereotactic radiotherapy .
Key inclusion criteria (4 listed)
- ≥ 18 years old
- Patients with a confirmed histopathological diagnosis of vestibular schwannoma
- Patients who received stereotactic radiosurgery (SRS) for schwannoma
- Patients with available data on clinical and radiological outcomes
Key exclusion criteria (2 listed)
- Patients who received other forms of radiotherapy, surgery, or experimental treatments for the schwannoma prior to stereotactic radiotherapy
- Medical records that are incomplete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy data on stereotactic radiotherapy for the treatment of schwannomas
Time frame: 6 months
MRI data (comparison of initial schwannoma volume with follow-up volume)
3 secondary outcomes
Side effects associated with stereotactic radiotherapy treatment
Time frame: 6 months
Survival
Time frame: 6 months
Quality of life assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel SCHER, M.D principal investigator
Hartmann Oncology Radiotherapy Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schwannoma, Vestibular, run by Hartmann Oncology Radiotherapy Group, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy data on stereotactic radiotherapy for the treatment of schwannomas (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.