NCT02514915

Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Christopher Wilke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Detailed description

Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.

Conditions

• Malignant Neoplasm Brain

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery	Radiation therapy

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2015-08-04
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study