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
Ayal A. Aizer, MD
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.
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 treatme…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria: 1. Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment 2. Abutment, to within 1.0cm, of a region of intracranial edema 3. Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment 4. Proximity (within 5.0cm) to another source of p…
Interventions
- RadiationLinear 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
Location
- Brigham and Women's Hospital / Dana-Farber Cancer InstituteBoston, Massachusetts