NCT03398694

Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases

A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.

Detailed description

Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases. Secondary Objectives * Overall survival * Distant in-brain progression * Rate of leptomeningeal spread * Rate of radiation necrosis

Conditions

• Brain Metastases

Interventions

Type	Name	Description
PROCEDURE	Radiosurgery	Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife or linear accelerator based techniques as per RTOG-9005 dosing criteria (Section 11 Table 1) based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time. Radiosurgery will be performed 1-4 days prior to surgical resection. Vital signs and MRI Brain planning scan will be performed on the day of radiosurgery prior to the procedure.

Timeline

• Start date: 2018-03-26
• Primary completion: 2022-08-26
• Completion: 2024-05-21
• First posted: 2018-01-12
• Last updated: 2024-07-16

Locations

3 sites across 1 country: United States