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Radiation

Hypofractionated Stereotactic Radiosurgery (SRS) for Meningioma (SRS-AIM Trial)

N/A
Waitlist Available
Led By William Chen, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age \>+ 18 years at time of study entry
* Ability to understand and the willingness to sign a written informed consent document.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This clinical trial tests the safety and effectiveness of hypofractionated stereotactic radiosurgery for treating patients who have undergone surgical resection for grade II meningiomas or grade I meningiomas that have come back after a period of improvement (recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Hypofractionated stereotactic radiosurgery may be safe, tolerable, and effective in treating patients with grade II or recurrent grade I meningiomas after surgical resection.

Who is the study for?
This trial is for patients who've had surgery for grade II meningiomas or recurrent grade I meningiomas. It's testing a shorter, high-dose radiation therapy called hypofractionated stereotactic radiosurgery (SRS) to see if it's safe and effective in treating these tumors.
What is being tested?
The study involves using advanced imaging techniques like CT and MRI to guide the SRS treatment. The goal is to precisely target tumor cells with higher doses of radiation over fewer sessions, potentially improving outcomes and reducing side effects.
What are the potential side effects?
Potential side effects may include skin irritation at the treatment site, fatigue, headaches, nausea, hair loss near treated areas, and short-term memory issues due to the high-dose radiation targeting brain tumors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with reported adverse events
Secondary study objectives
Frequency of responses on the Brief Work and Transportation Survey
Mean score Decision Regret Scale (DRS)
Mean score on the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) over time
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypofractionated Stereotactic Radiosurgery (SRS)Experimental Treatment3 Interventions
Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes QD on days 1-5 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography (CT)
2012
N/A
~100
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,537 Previous Clinical Trials
15,262,439 Total Patients Enrolled
American Society of Clinical OncologyOTHER
37 Previous Clinical Trials
148,126 Total Patients Enrolled
William Chen, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
~15 spots leftby Jul 2029