Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-04 @ 1:50 AM
Study NCT ID:
NCT04895592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiosurgery Before Surgery for the Treatment of Brain Metastases
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: a Two Arm Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
None
Brief Summary:
This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis.
SECONDARY OBJECTIVES:
I. To evaluate the immune niche in brain metastasis following SRS in the presence of low or high dose dexamethasone.
II. To evaluate the impact of pre-operative SRS on survival outcomes.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone orally (PO) or intravenously (IV) for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
ARM B: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
After completion of study intervention, patients are followed up for 120 days, and then every 12 weeks thereafter.
I. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis.
SECONDARY OBJECTIVES:
I. To evaluate the immune niche in brain metastasis following SRS in the presence of low or high dose dexamethasone.
II. To evaluate the impact of pre-operative SRS on survival outcomes.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone orally (PO) or intravenously (IV) for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
ARM B: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
After completion of study intervention, patients are followed up for 120 days, and then every 12 weeks thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2021-02761 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00001896 | None | None | View | |
| RAD5234-21 | OTHER | Emory University Hospital/Winship Cancer Institute | View | |
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |