NCT04545814

Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases

A Pilot Study Analyzing Preoperative Stereotactic Radiosurgery (SRS) With Gamma Knife (GK) for Brain Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single-center pilot study in which 10 patients with one to four brain metastases diagnosed on brain magnetic resonance imaging (MRI) within the past 30 days will be evaluated for study eligibility and enrolled as appropriate.

Detailed description

INTERVENTION: Enrolled patients will receive stereotactic radiosurgery (SRS) to all metastases followed by surgical resection of resectable metastases within one to 10 days following SRS. Pathologic specimens will be analyzed, and the patient will enter a standard pattern of surveillance (brain MRI every three months for two years). STUDY RATIONALE: Given the increased risk of leptomeningeal failure with surgery followed by SRS as well as the risk of radiation necrosis, new paradigms in therapy delivery and sequencing are being explored. Areas of investigation include optimization of target volume, marginal expansion, multi-fractionation, timeliness of SRS after surgery, and delivery of SRS prior to surgical resection. In theory, advantages of preoperative SRS include better target delineation, sterilization of tumor cells prior to surgical disruption of the tumor, vascular supply, and cerebrospinal fluid (CSF) spaces, and resection of tissue that would otherwise be at risk of radiation necrosis. In 2014, Asher, et al. reported that the use of neoadjuvant SRS prior to surgery was both safe and effective (even for metastases \>3 cm) with no reported leptomeningeal recurrences or radiation necrosis. More recently, Patel et al. performed a retrospective comparison of preoperative versus postoperative SRS and reported no difference in local control, distant brain failure, or overall survival. Furthermore, the authors reported significantly lower rates of leptomeningeal carcinomatosis and radiation necrosis with preoperative SRS. Huff, et al. recently published a protocol for a phase II prospective trial designed to compare outcomes using preoperative SRS versus historically cited outcomes for postoperative SRS. This pilot study mirrors this design and aims to confirm study feasibility and to assess local control, central nervous system (CNS) progression-free survival, overall survival, rates of leptomeningeal spread, rates of radiation necrosis, and quality of life measures with the use of preoperative SRS.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DEVICE	Stereotactic Radiosurgery	Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
PROCEDURE	Surgical Resection	Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
DEVICE	Magnetic Resonance Imaging	Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).

Timeline

• Start date: 2021-01-15
• Primary completion: 2024-08-22
• Completion: 2024-08-22
• First posted: 2020-09-11
• Last updated: 2026-03-24
• Results posted: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study