Clinical Trial

Evolution of Hypofractionated Stereotactic Irradiation for Radio-Resistant Brain Metastases From D1-3-5 to D1-2-3

Study acronym: SISMIC
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this prospective, multi-center, randomized double-arm clinical trial is to demonstrate a benefit in term of local control of a shorter spread of hypofractionated stereotactic radiotherapy at D1-2-3 vs D1-3-5, in the treatment of "radioresistant" Brain Metastases (BM). This trial aims to recruit patients with 1 to 5 unoperated BM originating from radioresistant primary sites. Patients will be randomly assigned to either the D1-3-5 radiotherapy arm or the D1-2-3 radiotherapy arm. Stereotactic brain irradiation will be administered at a dose of 33 Gy delivered in 3 fractions.
Trial Details
NCT Number NCT07167134
Lead Sponsor Centre Paul Strauss
Conditions Brain Metastases
Enrollment 264 participants
Start Date 2025-10
Primary Completion 2028-10 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2025-09-11