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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04895592
Study type Interventional
Source Emory University
Contact Zachary Buchwald, MD, PhD
Phone 404-778-1790
Email zachary.scott.buchwald@emory.edu
Status Recruiting
Phase Early Phase 1
Start date July 20, 2021
Completion date January 31, 2026

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