Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-16 @ 8:52 PM
Study NCT ID:
NCT06557512
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SRS-AIM
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.
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 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:
I. To prospectively collect and assess a prognostic and predictive gene expression panel biomarker and deoxyribonucleic acid (DNA) methylation based genomic classification systems for meningioma.
II. To report the comparative dosimetry of adjuvant stereotactic radiosurgery as compared to simulated external beam plans generated based on the drawn planning target volumes.
OUTLINE:
Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo magnetic resonance imaging (MRI) throughout the study and may undergo computed tomography (CT) as necessary.
After completion of study treatment, participants are followed up at months 3 and 6 and then at years 1, 2 and 3.
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:
I. To prospectively collect and assess a prognostic and predictive gene expression panel biomarker and deoxyribonucleic acid (DNA) methylation based genomic classification systems for meningioma.
II. To report the comparative dosimetry of adjuvant stereotactic radiosurgery as compared to simulated external beam plans generated based on the drawn planning target volumes.
OUTLINE:
Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo magnetic resonance imaging (MRI) throughout the study and may undergo computed tomography (CT) as necessary.
After completion of study treatment, participants are followed up at months 3 and 6 and then at years 1, 2 and 3.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-06542 | REGISTRY | NCI Clinical Trials Reporting Program (NCI CTRP) | View |