Phase II Study Comparing Different Stereotactic Radiotherapy Methods for Brain Metastases Evaluating Safety and Effectiveness of Hypofractionated Treatment

What this Trial Is About

Researchers are evaluating a new method of stereotactic radiotherapy for treating brain metastases in this randomized phase II trial. The study compares the current standard stereotactic radiotherapy SRT delivered in one or three doses with a fractionated approach fSRT given in five doses. The goal is to find a potentially safer treatment that reduces long-term side effects like brain necrosis, which affects up to 40% of patients depending on tumor size and radiation dose. One group of participants will receive SRT in one or three sessions with doses ranging from 8 Gy up to 15-24 Gy. The other group will receive fSRT spread over five sessions with doses of 7 Gy up to 35 Gy, or for brain stem metastases, five sessions of 6 Gy up to 30 Gy. This treatment phase compares these two radiation schedules to assess differences in safety and tumor control. Participants will be monitored for survival, side effects, and quality of life for two years after treatment. Researchers will track the occurrence of brain necrosis or tumor recurrence, need for additional treatments, brain recurrences, corticosteroid and anti-epileptic drug use, and any grade 2 or higher toxicities. This thorough follow-up includes patient-reported outcomes and medical assessments to understand the treatments impact over time.

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases