NCT07437820

Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases

Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).

Detailed description

This is a phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study designed to evaluate the efficacy in terms of local progression-free survival of neoadjuvant stereotactic radiotherapy for brain metastases compared with adjuvant stereotactic radiotherapy. The study population is composed of adult patients with 1 to 12 newly diagnosed brain metastases who require surgical treatment for the removal of at least one lesion. The two therapeutic strategies studied in the trial are as follows: * SRS NEO group (experimental group): stereotactic radiotherapy administered as neoadjuvant therapy (4 days ± 1 day before surgery to remove the brain metastasis). * POST OP SRS group (control group): stereotactic radiotherapy performed adjuvantly (4 to 6 weeks after surgery to remove the brain metastasis).

Conditions

• Brain Metastases, Adult

Interventions

Type	Name	Description
RADIATION	stereotactic radiotherapy	Stereotactic radiotherapy is part of the standard treatment for brain metastases.
PROCEDURE	Excision surgery	Brain metastasis removal surgery

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2026-02-27
• Last updated: 2026-03-04

Locations

1 site across 1 country: France