Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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 it's running

• 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: Francim Aguilar
• Email: Francim.Aguilar@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.