NCT06557512 Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
| NCT ID | NCT06557512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Meningioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23 participants in total. It began in 2024-12-13 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
William Chen, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06557512 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Meningioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557512 currently recruiting?
Yes, NCT06557512 is actively recruiting participants. Contact the research team at Francim.Aguilar@ucsf.edu for enrollment information.
Where is the NCT06557512 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06557512 clinical trial?
NCT06557512 is sponsored by University of California, San Francisco. The principal investigator is William Chen, MD at University of California, San Francisco. The trial plans to enroll 23 participants.