Status:
RECRUITING
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
American Society of Clinical Oncology
Conditions:
Meningioma
Meningioma, Malignant
Eligibility:
All Genders
18+ years
Phase:
NA
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 men...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06557512
Start Date
December 13 2024
End Date
September 30 2029
Last Update
January 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94143