NCT04422639

Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases

A Phase II Pilot Trial of Preoperative SRS/SRT Versus Postoperative SRS/SRT for Brain Metastases

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases. The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain metastases. The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain metastases will result in improved freedom from Central Nervous System (CNS) events when compared to adjuvant SRS/SRT after surgical resection.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
RADIATION	SRS/SRT	Comparing pre-operative SRS/SRT to post-operative SRS/SRT

Timeline

• Start date: 2020-08-24
• Primary completion: 2023-03-27
• Completion: 2023-03-27
• First posted: 2020-06-09
• Last updated: 2023-07-28
• Results posted: 2023-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study