A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)
University of California, San Francisco
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). 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.
Description
PRIMARY OBJECTIVE: I. To evaluate the safety of adjuvant hypofractionated stereotactic radiosurgery after gross total resection of intermediate risk meningioma. SECONDARY OBJECTIVES: I. 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:…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 U…
Interventions
- RadiationHypofractionated Stereotactic Radiosurgery (SRS)
Undergo Hypofractionated Stereotactic Radiosurgery
- ProcedureMagnetic Resonance Imaging (MRI)
Undergo MRI
- ProcedureComputed Tomography (CT)
Undergo CT imaging
Location
- University of California, San FranciscoSan Francisco, California