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MeningiomaSRS-AIMNCT06557512

Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

A study testing Hypofractionated Stereotactic Radiosurgery (SRS), Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) in people with Meningioma and Meningioma, Malignant, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hypofractionated Stereotactic Radiosurgery (SRS), Magnetic Resonance Imaging (MRI) and Computed Tomography (CT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
13 Dec 2024to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Age >+ 18 years at time of study entry
  • Ability to understand and the willingness to sign a written informed consent document.
  • Histologic diagnosis of newly diagnosed World Health Organization (WHO) grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO grade 1 meningioma, participants must present with radiographic evidence of recurrence, and have a histologic diagnosis of WHO grade 1 meningioma at the most recent resection.
  • Note: For participants diagnosed outside of University of California San Francisco (UCSF), re-review of pathology at UCSF is strongly encouraged. Hematoxylin and eosin (H\&E) slides will be reviewed by UCSF pathologists.
  • Participants must have undergone a gross-total surgical resection as deemed by their neurosurgeon (Simpson grade I-III resection), using all available information which can include post-operative MRI, of a meningioma within 180 days of enrollment.
  • Participants must have a pre-operative MRI.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70 or higher)
  • Participants must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery, as reviewed by the Radiation Oncology co-principal investigators (PIs).

Who cannot join

  • Concurrent participation in another clinical study with an investigational product unless it is an observational (non-interventional) study or the follow-up period of an interventional study.
  • Extensive multifocal (3 or more meningiomas) or metastatic disease.
  • Participants with tumors within 2mm of the optic apparatus or brainstem will be excluded.
  • Participants with another active primary malignancy or history of previous malignancy (except non-melanoma skin cancers, low and intermediate risk prostate cancers, and in situ cancers such as bladder, gastric, colon, cervical/dysplasia, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
  • Female participants who are pregnant.
  • Any underlying medical or psychiatric condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results.
  • Participants with uncontrolled seizures, defined as greater than 3 disabling seizures per day while on anti-epileptic drugs.
  • Participants who have had previous intracranial radiotherapy overlapping with the area that would be targeted for stereotactic radiosurgery by this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of California, San Francisco

    San Francisco, California, 94143

    Francim Aguilar, Francim.Aguilar@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the safety of adjuvant hypofractionated stereotactic radiosurgery after gross total resection of intermediate risk meningioma.

SECONDARY OBJECTIVES:

  1. To report the efficacy of adjuvant hypofractionated stereotactic radiosurgery in participants with intermediate risk meningioma.

II. To evaluate the 3-year overall survival rate of participants treated with adjuvant stereotactic radiosurgery.

III. To report on the financial impact, quality of life, and treatment burden of participants who undergo adjuvant stereotactic radiosurgery.

EXPLORATORY OBJECTIVES:

  1. To prospectively collect and assess a prognostic and predictive gene expression panel biomarker and deoxyribonucleic acid (DNA) methylation based genomic classification systems for meningioma.

II. To report the comparative dosimetry of adjuvant stereotactic radiosurgery as compared to simulated external beam plans generated based on the drawn planning target volumes.

OUTLINE:

Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo magnetic resonance imaging (MRI) throughout the study and may undergo computed tomography (CT) as necessary.

After completion of study treatment, participants are followed up at months 3 and 6 and then at years 1, 2 and 3.

Being tested
Hypofractionated Stereotactic Radiosurgery (SRS), Magnetic Resonance Imaging (MRI), Computed Tomography (CT)
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Stereotactic Radiosurgery (SRS)Radiation

    Also called Fractionated Stereotactic Radiation Therapy, SRS

    Undergo Hypofractionated Stereotactic Radiosurgery

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    Also called MRI, MR

    Undergo MRI

  • Computed Tomography (CT)Procedure or surgery

    Also called CT

    Undergo CT imaging

Study groups in NCT06557512
Study groupRoleWhat they receive
Hypofractionated Stereotactic Radiosurgery (SRS)ExperimentalParticipants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes QD on days 1-5 in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Hypofractionated Stereotactic Radiosurgery (SRS); Procedure: Magnetic Resonance Imaging (MRI); Procedure: Computed Tomography (CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with reported adverse events

    Adverse events will be classified and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of CTCAE grade 3-5 toxicity within 1 year of radiation will be estimated along with the exact 90% confidence interval.

    Measured: Up to 1 year

Secondary outcomes (10)
  1. Median Local Freedom from recurrence (LFFR)

    Local freedom from recurrence (LFFR) is defined as time from start of treatment to date of an event as defined by the above criteria, dated to the imaging study date on which recurrence was assessed. The 3-year LFFR will be estimated by the Kaplan-Meier method. Median LFFR will be estimated, if possible, from the Kaplan-Meier method.

    Measured: Up to 3 years

  2. Median Progression-Free Survival (PFS)

    Progression free survival (PFS) is defined as the duration of time from start of treatment to date of death or progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, dated to the imaging study date on which PD was assessed. The 3-year PFS will be estimated by the Kaplan-Meier method. Median PFS will be estimated, if possible, from the Kaplan-Meier method.

    Measured: Up to 3 years

  3. Median overall survival (OS)

    Overall survival (OS) is defined as the duration of time from start of treatment to date of death or censored at the date of final visit if lost to follow-up. The 3-year OS will be estimated by the Kaplan-Meier method. Median OS will be estimated, if possible, from the Kaplan-Meier method.

    Measured: Up to 3 years

  4. Mean score on the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) over time

    The COST-FACIT is an 11-item measure used to assess financial toxicity. Each item is measured on a five-point Likert scale (0 = not at all, 4 = very much), with recall based on the past 7 days related to the participant's disease management. A score is computed by first reverse coding seven items, then taking the sum of all items, multiplying the sum by 1the number of items on the scale, and dividing that number by the number of items answered. Higher scores indicate better Financial Well-Being.

    Measured: Up to 3 months

  5. Frequency of responses on the Brief Work and Transportation Survey

    The Brief Work and Transportation Survey contains 10-items modeled after items from the National Health Interview Survey asking participants information about current employment, time taken off work for cancer treatment, the transportation burden, and time burden of treatment). Items will be reported categorically based on most frequent response.

    Measured: Up to 3 months

  6. Mean score Decision Regret Scale (DRS)

    The 5-item Decision Regret Scale was developed to measure regret after health-care decisions Item responses are scored on a scale from 1 (strongly agree) to 5 (strongly disagree). Two of the items are reverse coded and total scores are transformed to a scale of 0-100 by subtracting 1 from each item then multiply the response by 25. To obtain a final score the items are summed and averaged. A score of 0 means no regret and a score of 100 indicates very high regret.

    Measured: Up to 1 year

  7. Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Global Health Status over time

    The global health status score consists of responses to two items with responses ranging from 1="very poor" to 4="excellent". The raw score is calculated by estimating the mean of the two items that make up the global health scale with a resulting total range of 1-7. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the global health status represents a higher quality of life.

    Measured: Up to 3 years

  8. Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Functional Domains over time

    The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning

    Measured: Up to 3 years

  9. Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Symptoms over time

    The Pain score consists of responses to two items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the two items that make up the pain scale with a resulting total range of 1-4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the pain scale / item represents a high level of symptomatology / problems.

    Measured: Up to 3 years

  10. Mean score on the EORTC QLQ Brain Cancer Module (BN20) over time

    The EORTC QLQ-BN20 consists of 20 questions; seven single item symptom scales (headaches, seizures, drowsiness, hair loss, itchy skin, leg weakness and bladder control), along with four multi-item scales (future uncertainty, visual disorder, motor dysfunction and communication deficit). Raw scores for the QLQ-BN20 items are computed by calculating the mean of the items in each subscale, or the item for each individual and linearly transform the scores to a 0-100 scale. A higher score represents worse QOL for all QLQ-BN20 scales and single items.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start13 Dec 2024
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06557512
Sponsor's protocol ID
24724
Other IDs
NCI-2024-06542
Acronym
SRS-AIM
Status last verified
Aug 2026
First submitted
13 Aug 2024
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated Stereotactic Radiosurgery (SRS), Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) in people with Meningioma and Meningioma, Malignant, run by University of California, San Francisco at 1 site in United States.

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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francim Aguilar (877-827-3222, Francim.Aguilar@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with reported adverse events (time frame: Up to 1 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 26 Aug 2026.

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