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.
Without a stereotactic frame there is considerable variation in practice in the use of planning target volume (PTV) margins for linac radiosurgery. In particular, the use of a single isocenter for multiple targets geometrically increases the risk that rotational errors will result in significant dosimetric errors, and many centers have considered adding margin. A recent AAPM task group survey has found that \~90% of centers worldwide add a PTV margin to account for error and that 8% add more than 2 mm. The most common margin is 2 mm. Other potential reasons to add a margin include spacial MRI error, couch walkout, CBCT to linac isocenter mismatch, and undetected intrafraction motion. Treatment volume is the greatest predictor of radiation toxicity associated with radiosurgery and potentially unnecessary margins will lead to increased risk to the patient. This trial will incorporate a composite endpoint that includes control of the tumor and toxicity. Uncomplicated tumor control probability (UTCP) is defined as the chance the tumor is locally controlled (TCP) without grade 3 or greater CNS toxicity (1-NTCP). The investigators hypothesize a 2 mm margin will worsen uncomplicated control compared to a 0 mm PTV margin in the treatment multiple metastases in a single fraction. This trial will inform the standard of care margin (0 mm vs 2 mm) for single isocenter treatment of multiple targets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
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.
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, United States
RECRUITINGDifference 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.
Time frame: 12 months
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
Time frame: 12 months
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)
Time frame: 12 months
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)
Time frame: 12 months
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