This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment.
Be willing and able to provide written informed consent/assent for the trial
Be ≥ 18 years of age on day of signing informed consent.
Have histologically confirmed renal cell carcinoma with metastatic disease detected on imaging. Biopsy of metastasis is preferred but not required
The subject has a performance status of 0, 1, or 2 on the ECOG Performance Scale
Has had radiation therapy within 2 weeks of the first protocol treatment.
Has brain-only oligoprogression. subjects with brain and systemic oligoprogression can still be considered, however treatment of brain metastases will be per standard of care prior to receiving study SBRT.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks of the first protocol treatment. The use of lowdose steroids for management of chronic conditions is allowed (up to 12mg prednisone orally per day or the equivalent).
Has had prior radiation therapy within 2 weeks of the first protocol treatment.
Single group
Stereotactic Body Radiation Therapy
Radiation1-5 fraction Stereotactic Body Radiation Therapy to all sites of progression
Progression Free Survival
The primary objective of this study is to assess progression free survival after SBRT to all sites of progression and continuation of the same systemic regimen in patients with mRCC on ICI-containing systemic regimens with oligoprogression at 1-5 sites. Progression will be defined by RECIST criteria.
Recurrence
Imaging will be done every three months to determine rate of recurrence.
Rate of Response
To determine rate of response at non-treated sites. Imaging will be done every three months.
Overall survival
Overall survival will be assessed up to two years
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