Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)
This single center pilot trial is designed to demonstrate the safety of adjuvant hypofractionated stereotactic radiosurgery for patients after gross total of resection of intermediate risk meningioma.
As an alternative to 6 weeks of fractionated 3D-conformational radiotherapy and intensity modulated radiation therapy, hypofractionated stereotactic radiosurgery (30Gy in 5 fractions) may represent a more optimal modality for targeting an anisotropic radiation target of at-risk dura, allowing for a steeper dose-gradient, better sparing of uninvolved brain parenchyma, and a substantial reduction in treatment duration.
This study will report on safety of a prospective trial of adjuvant hypofractionated SRS for intermediate risk meningioma as measured by the proportion of grade 3 or higher toxicity at 1 year (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events).
- 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 WHO grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO grade 1 meningioma, patients must present with radiographic evidence of recurrence, and have a histologic diagnosis of WHO grade 1 meningioma at the most recent resection. (Note: For patients diagnosed outside of UCSF, re-review of pathology at UCSF is strongly encouraged. H&E slides will be reviewed by UCSF pathologists.)
- Patients 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 enrolment.
- Patients must have a pre-operative MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70 or higher).
- Patients must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery, as reviewed by the radiation oncology co-principal investigators.
For the most up-to-date list of criteria, please visit clinicaltrials.gov.
- 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.
- Patients with tumors within 2mm of the optic apparatus or brainstem will be excluded.
- Patients 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 patients 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 patient safety or study results.
- Patients with uncontrolled seizures, defined as greater than 3 disabling seizures per day while on anti-epileptic drugs.
- Patients who have had previous intracranial radiotherapy overlapping with the area that would be targeted for stereotactic radiosurgery by this study.
For the most up-to-date list of criteria, please visit clinicaltrials.gov.
