Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 1b Study of Safety and Preliminary Efficacy of Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Renal Cell Carcinoma Treated With Targeted or Immuno- Therapy (Volga Study).
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.
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