NCT07132190

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

A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ayal A. Aizer, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields. Participants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation/radiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation/radiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.

Detailed description

Adaptively designed radiation, which adjusts a given radiation plan for real time changes in patient position or anatomy, has become a standard approach within many oncologic entities to combat the effect of shifts between simulation and treatment. Adaptively planned SRS/SRT with same day brain MRI and treatment delivery offers potential to quantify the impact of treatment planning time while also reducing margins and potentially improving rates of local recurrence and radiation necrosis. This trial aims to explore the viability of adaptively designed SRS/SRT with same day planning and treatment in combination with tighter planning margins in both controlling brain metastases locally and minimizing the risk of radiation necrosis in a phase 2 randomized study. Participants will have a preliminary stereotactic treatment plan created from a diagnostic brain MRI indicating the need for treatment. The preliminary plan will undergo departmental-standard physics, therapy, and quality assurance checks, spanning a total of 1-2 weeks, after which the patient will return for treatment. On the day of treatment (SRS) or start of treatment (SRT), a repeat MRI brain will be performed for planning purposes on an MRI simulator. A synthetic computed tomography (CT) scan will be generated from the new MRI. The previously generated contours and plan will be adapted to the new MRI and the fused synthetic CT. Lastly, the treatment will be delivered. The primary objective is to assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment. An important secondary objective is to quantify local recurrence and radiation necrosis rates in patients treated with same day simulation and treatment, based on randomization to a PTV of 0mm or 1.0mm.

Conditions

• Brain Metastases, Adult
• Brain Tumor - Metastatic
• Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
• Brain Metastases From Extra-cranial Solid Tumors

Interventions

Type	Name	Description
RADIATION	Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV	Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2025-08-20
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study