Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hypofractionated Stereotactic Radiosurgery (SRS)
- Magnetic Resonance Imaging (MRI)
- Computed Tomography (CT)
Treatment groups
23 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, San Francisco
Lead sponsor
American Society of Clinical Oncology
Collaborator
Source ClinicalTrials.gov