Actively Recruiting
A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)
Led by University of California, San Francisco · Updated on 2026-05-18
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
A
American Society of Clinical Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of hypofractionated stereotactic radiosurgery in patients who have had surgery for grade II meningiomas or recurrent grade I meningiomas. This study aims to assess this specialized radiation treatment, which uses focused high-energy rays to target tumor cells, after surgical removal of these brain tumors. It also explores survival rates, quality of life, financial impact, and gathers genetic information related to meningioma. The treatment involves a course of hypofractionated stereotactic radiosurgery delivered once daily over five consecutive days, each session lasting 15 to 30 minutes, provided there is no disease progression or unacceptable side effects. Participants also undergo regular imaging tests, including magnetic resonance imaging (MRI) throughout the study and computed tomography (CT) scans as needed. After completing the treatment, participants are followed up at 3 and 6 months, then annually for up to three years. During the study, participants will have their safety monitored by tracking any adverse events for up to one year. Researchers will also evaluate tumor control and survival outcomes over three years, along with assessing quality of life, financial burden, and treatment regrets using standardized questionnaires. Imaging tests help monitor disease status, and participants' overall health and function will be regularly assessed to understand the treatment's impact over time.
CONDITIONS
Brief Title
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of study entry
- Ability to understand and willing to sign informed consent
- Histologic diagnosis of newly diagnosed WHO grade 2 or recurrent WHO grade 1 meningioma with recent recurrence evidence
- Gross-total surgical resection of meningioma within 180 days before enrollment
- Pre-operative MRI available
- ECOG performance status 0 or 1 (Karnofsky score 70 or higher)
- Post-operative MRI anatomy suitable for hypofractionated radiosurgery as reviewed by investigators
You will not qualify if you...
- Concurrent participation in another interventional clinical study (except observational)
- Extensive multifocal disease with 3 or more meningiomas or metastatic disease
- Tumors located within 2mm of the optic apparatus or brainstem
- Another active primary malignancy or recent malignancy unless in remission for 2 years without ongoing therapy
- Pregnant female participants
- Medical or psychiatric conditions interfering with safety or study evaluation
- Uncontrolled seizures with more than 3 disabling seizures per day on medication
- Previous intracranial radiotherapy overlapping the study treatment area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants undergo hypofractionated stereotactic radiosurgery once daily on days 1 through 5, with each session lasting 15 to 30 minutes, unless disease progression or unacceptable toxicity occurs.
5 daily visits (in-person)
Duration - Up to 3 years
Participants are followed up with imaging and assessments to monitor health and treatment effects after completing radiosurgery.
Visits at 3 and 6 months, then at 1, 2, and 3 years
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
F
Francim Aguilar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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