Protocol: WF-2201
Please Note: Below is a brief list of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 or (810)762-8038, to discuss the full list of eligibility.
Eligibility:
- At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume with no prior history of radiation therapy for brain metastasis. • Both patients at initial diagnosis of brain metastases and patients known brain metastasis treated with systemic therapy alone are eligible
• Lesion volume will be approximated by measuring the lesion’s three perpendicular diameters on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided
by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice-by-slice contouring on a treatment planning software package can be used to
calculate the total tumor volume.
• Any extent of non-CNS disease is allowed. There is no requirement for non-CNS disease to be controlled prior to study entry. - Age ≥ 18 years at the time of enrollment.
- Total number of brain metastases (including resection cavities) < 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist.
Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options. - Total gross tumor volume must be < 30 cc. Lesion volume will be approximated by measuring each lesion’s three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.
- Ability to tolerate MRI brain with gadolinium-based contrast.
- Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer, or breast cancer.
- Has received, is currently receiving, or is planned to receive immune checkpoint inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of the planned first day of
SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4 targeted agents are allowed, but patients treated with a single agent CTLA-4 targeted agent only are ineligible.