Vestibular SchwannomaPhase 3NCT01449604
Stereotactic Radiation in Vestibular Schwannoma
A Phase 3 study testing stereotactic radiotherapy and stereotactic radiosurgery in people with Vestibular Schwannoma, run by Ramathibodi Hospital.
Trial summary
The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- stereotactic radiotherapy and stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vestibular schwannoma tumor size not more than 3 cm.
Who cannot join
- NF 2 patient
- underlying cerebrovascular disease
- tumor compress and efface brain stem ( Koos 4)
About this study
Official title: Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).
Read the detailed description
Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial.
Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.
- Conditions
- Vestibular Schwannoma
- Being tested
- stereotactic radiotherapy, stereotactic radiosurgery
- Keywords
- Stereotactic radiotherapy, SRS, SRT, vestibular schwannoma
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiotherapyRadiation
Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
stereotactic radiosurgeryRadiation
Also called SRS
Radio surgery 12 Gy
| Study group | Role | What they receive |
|---|---|---|
| stereotactic radiosurgery | Active comparator | Radio surgery single fraction 12 Gy Receives: Radiation: stereotactic radiosurgery |
| stereotactic radiotherapy | Active comparator | Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction Receives: Radiation: stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
audiogram
change from baseline audiogram at 6 months,1 year and 2 year
Measured: two year
Secondary outcomes (2)
number of participant with adverse event
the new number of adverse event after radiation at 6 month,1 and 2 year
Measured: 2 year
tumor size
change in tumor size at 6 month, 1 year and 2 year
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putipun Puataweepong, Ramathibodi Hospital
- Investigators
- Putipun Puataweepong, M.D., Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449604
- Sponsor's protocol ID
- RAMART0111
- Status last verified
- Oct 2011
- First submitted
- 2 Oct 2011
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
- ClinicalTrials.gov ID
- NCT01449604
- Acronym / sponsor ID
- RAMART0111
- Conditions
- Vestibular Schwannoma
- Keywords
- Stereotactic radiotherapy, SRS, SRT, vestibular schwannoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 10 Oct 2011 (estimated)
- 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.
The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).
Detailed description
Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial.
Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stereotactic radiosurgery | Active comparator | Radiation: stereotactic radiosurgeryRadio surgery single fraction 12 Gy |
| stereotactic radiotherapy | Active comparator | Radiation: stereotactic radiotherapyStereotactic radiotherapy hypo fraction 18 Gy in 3 fraction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- vestibular schwannoma tumor size not more than 3 cm.
Key exclusion criteria (3 listed)
- NF 2 patient
- underlying cerebrovascular disease
- tumor compress and efface brain stem ( Koos 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic radiotherapyStereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions | Radiation | stereotactic radiotherapy |
| stereotactic radiosurgeryAlso: SRSRadio surgery 12 Gy | Radiation | stereotactic radiosurgery |
Primary outcome
audiogram
Time frame: two year
change from baseline audiogram at 6 months,1 year and 2 year
2 secondary outcomes
number of participant with adverse event
Time frame: 2 year
tumor size
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
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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.
Putipun Puataweepong, M.D. principal investigator
Ramathibodi Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stereotactic radiotherapy and stereotactic radiosurgery in people with Vestibular Schwannoma, run by Ramathibodi Hospital.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
audiogram (time frame: two year). 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 10 Oct 2011.