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

Not Applicable

Completed

• Conditions: Brain Metastases
• Interventions: Procedure: Radiosurgery

• Registration Number: NCT03398694
• Lead Sponsor: Indiana University

Brief 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-12
• Study Start: 2018-03-26
• Primary Completion: 2022-08-26
• Study Completion: 2024-05-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Radiosurgery	This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-4 days prior to surgical resection.

Primary Outcome Measures

Name	Time	Method
Rate of local control of any new, recurrent, or progressing tumors within the planning target volume	6 months	Measured by post-treatment MRI

Secondary Outcome Measures

Name	Time	Method
Rate of in-brain progression free survival	6 months, 1 year, and 2 years	Time from start of treatment to any in-brain
Rate of overall survival	6 months, 1 year, and 2 years	Time from start of treatment to death of any cause
Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume)	2 years	Measured by post-treatment MRI
Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis)	2 years	Measured by post-treatment MRI
Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease)	2 years	Measured by post-treatment MRI

Trial Locations

Locations (3)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States