Phase 2 Study of Stereotactic Radiotherapy for Brain Metastases with Recent Bleeding

What this Trial Is About

Researchers are evaluating the safety and effectiveness of fractionated stereotactic radiotherapy FSRT to treat hemorrhagic brain metastases in adults. This Phase 2 trial focuses on patients with recent bleeding within brain metastases and aims to observe complications related to hemorrhage and tumor response after treatment. The study is sponsored by Centre Francois Baclesse and involves patients diagnosed with solid tumors that have spread to the brain. Each brain metastasis, whether hemorrhagic or not, will be treated with FSRT. The treatment consists of delivering a total radiation dose of 30 Gy divided into 3 fractions of 10 Gy each, given over 7 days. Patients eligible for stereotactic radiotherapy are selected by a multidisciplinary committee. The study is conducted in two stages, focusing on patients with specific tumor size and location criteria. Participants will undergo assessments including imaging to monitor for any new or increased bleeding and to evaluate tumor response according to standardized criteria six months after completing radiation therapy. Researchers will also evaluate neurological status, treatment tolerance, and any complications. The total duration of monitoring includes safety and tumor response evaluations at six months post-treatment, with ongoing observation as required by the study protocol.

Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal