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Radiation

Stereotactic Radiosurgery 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

Participants must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery

Age > 18 years at time of study entry

Must not have

Extensive multifocal or metastatic disease

Tumors within 2mm of the optic apparatus or brainstem

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a type of radiation therapy called hypofractionated stereotactic radiosurgery for patients with grade II or recurrent grade I meningiomas. This treatment delivers high doses of radiation in a

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

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My post-surgery MRI shows I'm a candidate for targeted radiation therapy.

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I am older than 18 years.

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I have a grade 2 meningioma or a recurring grade 1 meningioma confirmed by tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread extensively.

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My tumor is close to my optic nerve or brainstem.

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I am currently pregnant.

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I have seizures that are not controlled by medication.

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I've had brain radiotherapy in the same area targeted by this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Magnetic Resonance Imaging (MRI)

2015

Completed Phase 4

~1800

Computed Tomography (CT)

2012

N/A

~100