NCT05341739

A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

A Phase II Study of Pre-Operative Stereotactic Radiosurgery Followed by Surgical Resection for Brain Metastases

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.

Detailed description

Patients with a solid tumor malignancy that has metastasized to the brain are invited to participate in this trial. Upon enrollment to this study a subject will undergo stereotactic radiosurgery (SRS) using the Elekta Gamma Knife Icon, being treated in once daily 15 minute fractions of 9 Gray (Gy) or every other day 15 minute fractions of 9 Gy for a total dose of 27 Gy in 3 doses. A subject will undergo a routine CT and MRI simulation to determine positioning of the head prior to the start of the SRS treatment. Within two (2) weeks after completion of SRS a subject will undergo a routine surgical resection of the brain metastasis. Prior to the SRS treatment and during the follow up phase of the study MRIs will be performed, which are standard of care. Subjects will also complete a quality of life questionnaire. The duration of subject's time participating in this study is 2 years.

Conditions

• Brain Metastases, Adult

Interventions

Type	Name	Description
OTHER	Pre-operative Stereotactic Radiosurgery	Pre-operative SRS will be performed prior to the surgical resection of the brain metastases.

Timeline

• Start date: 2021-12-14
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2022-04-22
• Last updated: 2025-03-05

Locations

1 site across 1 country: United States