NCT03368625

A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases

A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).

Detailed description

Recently, a novel treatment strategy for large brain metastases was described whereby lesions appropriate for resection were treated with a single fraction of SRS pre-operatively. In a retrospective analysis, of 51 lesions with a median tumor size of 3 cm, 1-year LC was 86%. This neoadjuvant approach resulted in lower rates of leptomeningeal failure (3 vs. 17%) and symptomatic radiation toxicity (1.5 vs. 14.6 %) compared to a comparative cohort of lesions treated with post-operative cavity boost SRS (POCBS). Based on promising results, we believe that a prospective trial to establish the value of neoadjuvant SRS (NaSRS) for the treatment of BM appropriate for resection is warranted. This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).

Conditions

• Brain Metastases

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery	Stereotactic Radiosurgery before surgical resection of brain mets.

Timeline

• Start date: 2018-03-19
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2017-12-11
• Last updated: 2026-03-04

Locations

2 sites across 2 countries: Canada, Germany