Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR, mTOR or immune checkpoint inhibitors.
This is prospective phase 1b study. Patients with metastatic RCC receiving targeted or IO therapy (VEGFR inhibitor or mTOR inhibitor or checkpoint inhibitors in approved treatment lines and in standard therapeutic regimens) with stable diseaseor durable partial response for at least 4 months, are enrolled in the study. The initial examination includes CT with contrast, where the selected measured 2 metastatic sites, stable for at least 4 months but no more than 6 months of targeted therapy (increase or decrease in size in the course of targeted therapy should not exceed 10%). Metastases have to be located in one organ. Allowed location of metastases: lungs, liver, lymph nodes, contralateral kidney, adrenal gland. Size of selected metastases should not be less than 5 mm and not more than 4 cm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Dose and schedule will be depended on metastases location.
Ulyanovsk regional cancer center
Ulyanovsk, Ulyanovsk Oblast, Russia
Rate of adverse events of SBRT
Time frame: 4 months
Rate of reduction in size of first metastasis exposed to radiation
Time frame: 4 months
Time to progression of first (study) and second (control) metastases
Time frame: 8 months
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