Phase II Study Comparing One-Day Versus Five-Day Targeted Radiation Treatment for Adults With Brain Metastases and Poor Prognosis

What this Trial Is About

This research aims to compare two targeted radiotherapy approaches for patients with brain metastases who have a poor prognosis. The study evaluates whether a single high dose of 8 Gy given in one treatment session is not worse than the standard approach of 20 Gy delivered over five sessions in terms of overall survival. The goal is to find a simpler, faster treatment option that maintains survival outcomes for these patients. Participants will be randomly assigned to receive one of two treatments either five sessions of 4 Gy each using volumetric modulated arc therapy on a conventional linear accelerator or a single session of 8 Gy using the same technology and setup. Both treatments target brain metastases specifically without using stereotactic radiosurgery techniques. The study includes follow-up imaging and monitoring to track disease control and treatment effects. During the trial, participants will undergo regular assessments including brain imaging, performance status evaluations, corticosteroid use monitoring, and quality of life questionnaires. The study will measure overall survival over one year, along with secondary outcomes such as time to decline in performance status, control of brain metastases, need for retreatments, adverse events, and health-related quality of life. Participants will be followed for up to one year to evaluate these outcomes and safety.

RAPid SimPLE Targeted Radiation Treatment for Brain Metastases