Phase 2 Randomized Study of Same-Day Planning and LINAC-Based Stereotactic Radiation with Margin Reduction for Treating Brain Metastases

What this Trial Is About

Researchers are evaluating a new approach to brain-directed stereotactic radiation for patients with brain metastases that grow or change. The study aims to test the feasibility and effectiveness of same-day radiation planning and treatment with reduced planning margins. This phase 2 randomized trial explores whether shorter intervals between radiation planning and delivery improve targeting accuracy and potentially reduce local recurrence and radiation-related side effects. Participants will be randomly assigned to receive stereotactic radiation with either no margin 0mm or a 1mm margin around the tumor. On the day of treatment, patients undergo a repeat brain MRI and synthetic CT scan for updated radiation planning. The treatment plan is adapted based on these same-day images before delivering the radiation. Additional imaging may be done during treatment if more than 2-3 days elapse between scans. Throughout the study, participants will be monitored with diagnostic MRIs and various assessments for up to one year. Researchers will measure how often tumors extend beyond planned margins at treatment start, local tumor control, radiation necrosis, neurocognitive function, quality of life, survival outcomes, and other neurological events. This detailed follow-up includes neurocognitive tests and symptom questionnaires to understand the impact of the treatment approach.

Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction