NCT04895592

Radiosurgery Before Surgery for the Treatment of Brain Metastases

Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: a Two Arm Pilot Study

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Malignant Neoplasm in the Brain
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO or IV
PROCEDURE	Resection	Undergo surgical resection
RADIATION	Stereotactic Radiosurgery	Undergo SRS

Timeline

• Start date: 2021-07-20
• Primary completion: 2026-02-19
• Completion: 2027-02-19
• First posted: 2021-05-20
• Last updated: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study