About this trial
Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 19 and older
Brain metastases diagnosis not requiring retreatment to the same tumor
For females of reproductive potential should undergo pregnancy testing as per UAB Radiation Oncology standard policies
Disqualifiers
Current use of cytotoxic chemotherapy within 3 days of treatment. There are no restrictions on the use of immunotherapy during treatment. TKIs known to be radiation sensitizers such as BRAF should be held at least 24 hours prior to treatment.
Inability to have MRI imaging
Pregnancy
Treatment with another investigational drug 14 days of enrollment
Trial design
Single group
Treatments tested in this trial
brain metastases radiosurgery
Procedure/SurgeryRadiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.
Treatment groups
Trial outcomes
Primary outcomes
Difference between 0mm and 2mm
Fisher's Exact Test to determine if (per patient) uncomplicated control is improved or worsened with the addition of a 2mm PTV margin in the treatment of brain metastases with single isocenter radiosurgery.
Secondary outcomes
Maximum margin size of the tumor
To compare 0mm margin and 2mm margin radiosurgery for local tumor control, RANO assessment by individual tumor calculated by multiplying the longest diameter on an axial slice and its longest perpendicular diameter on the same slice
Percentage of toxicity
To compare 0mm margin and 2mm margin radiosurgery for toxicity. NTCP - assessed per tumor and per patient, assign to all tumors if attribution ambiguous (only grade 3 or greater CNS toxicity included)
Change in normal brain dosimetry
To compare 0mm margin and 2mm margin radiosurgery for normal brain dosimetry. * Dosimetry of normal brain (2 mm vs 0 mm) * Dosimetry of hippocampi (2 mm vs 0 mm)
Sponsors and contacts
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