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.
Additional locations may be listed on ClinicalTrials.gov for NCT04895592.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Zachary S. Buchwald
Phone: 404-778-1790
 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 1-14 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 1-14 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.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorZachary S. Buchwald