Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)
This study is testing a new way of giving radiation therapy over five days to see if it helps people with certain types of brain tumors feel better and have a better quality of life after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06557512 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of hypofractionated stereotactic radiosurgery in patients who have had surgical resection for grade II meningiomas or recurrent grade I meningiomas. The approach involves delivering higher doses of radiation over a shorter period, potentially killing more tumor cells while minimizing side effects. Participants will undergo treatment over five days, with follow-up assessments including MRI and CT scans to monitor outcomes. The study also aims to assess the financial impact and quality of life for participants post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a histologic diagnosis of newly diagnosed grade II or recurrent grade I meningioma who have undergone gross-total surgical resection.
Not a fit: Patients with grade I meningiomas that have not recurred or those who have not undergone surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and tolerable option for patients with intermediate-risk meningiomas.
How similar studies have performed: Other studies have shown promise with stereotactic radiosurgery approaches, but this specific hypofractionated method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 favourable-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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: William Chen, MD — University of California, San Francisco
- Study coordinator: Jamese Johnson
- Email: Jamese.Johnson@ucsf.edu
- Phone: (415) 530-9805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.