Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557512
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma SRS-AIM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None