Spots Global Cancer Trial Database for Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy

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Trial Identification

Brief Title: Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy

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).

Study ID: NCT02864615

Conditions

Metastatic Renal Cell Carcinoma

Interventions

SBRT

Study Description

Brief Summary: 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.

Detailed Description: 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.