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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

Who can join

Ages 18 and older · All sexes

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 physical displacement
2. Age of at least 18 years
3. Karnofsky performance status of at least 60
4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
5. Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium

Exclusion Criteria:

1. Participants who cannot tolerate a brain MRI
2. Patients who cannot receive gadolinium
3. Participants with end stage renal disease
4. Participants with widespread, definitive leptomeningeal disease
5. 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

About the study

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.

What is being tested

• Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV (radiation)

Sponsor: Ayal A. Aizer, MD · Participants: 60 · Started: Dec 30, 2025

Contact the study team

• Ayal A Aizer, MD, MHS · Phone: (617) 732-7560
• Marciana F Johnson, MPH · Phone: (617) 582-8335

Official record on ClinicalTrials.gov — NCT07132190

Locations in the U.S.

Conditions

• Brain Tumors
• Margins of Excision

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.