Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and… (NCT07132190) | Clinical Trial Compass
RecruitingPhase 2
Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction
United States60 participantsStarted 2025-12-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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
✓. Age of at least 18 years
✓. Karnofsky performance status of at least 60
✓. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
Exclusion criteria
✕. Participants who cannot tolerate a brain MRI
What they're measuring
1
To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment.
Timeframe: Diagnostic MRI to MRI on first day of treatment
✕. Participants with widespread, definitive leptomeningeal disease
✕. Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study as well