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.
Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
Abutment, to within 1.0cm, of a region of intracranial edema
Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
Proximity (within 5.0cm) to another source of physical displacement
Participants who cannot tolerate a brain MRI
Patients who cannot receive gadolinium
Participants with end stage renal disease
Participants with widespread, definitive leptomeningeal disease
Parallel
Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
RadiationLinear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment.
Percentage of patients, based on clinical and radiographic assessment, in which the repeat same day/simulation MRI reveals tumor extending beyond a 1.0mm PTV margin of the plan developed on the diagnostic MRI (i.e. the percentage of patients for which the MRI obtained on the same or first day of treatment displays tumor extending 1.0mm beyond the extent of the tumor on the planning MRI).
Overall survival
Clinical parameter
Death due to neurologic disease progression
Clinical assessment via review of study visits and medical records indicating cause of death (neurologic versus non-neurologic)
Performance status
Karnofsky performance status (KPS), assessed longitudinally. A higher score indicates better functional status and less dependence on others.
Progression free survival
Clinical assessment of first progression after treatment
Click on the lead sponsor to view all of their trials.
Ayal A. Aizer, MD
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Varian, a Siemens Healthineers Company
Collaborator
