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A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)

Protocol No
ALLIANCE-A031801-RADICAL
Principal Investigator
Deepak Kilari
Phase
II
Summary
The purpose of this study is to compare the usual treatment (cabozantinib alone) to using Radium-223 dichloride plus cabozantinib. The addition of Radium-223 dichloride to cabozantinib could help lessen the pain and symptoms from the cancer that has spread to the bone. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the symptoms related to cancer that has spread to the bone will improve with the addition of Radium-223 dichloride. The drug cabozantinib alone is already approved by the FDA for use in advanced renal cell cancer. Radium-223 dichloride is approved by the FDA, but not for advanced renal cell cancer. The combination of cabozantinib and Radium-223 dichloride is investigational. There will be about 210 people taking part in this study
Description
Cabozantinib + New Anti-cancer Drug Radium-223 Dichloride for Advanced RCC that's Spread to the Bone
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL