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

Protocol No

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

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

Cabozantinib + New Anti-cancer Drug Radium-223 Dichloride for Advanced RCC that's Spread to the Bone
Participating Institutions
Froedtert Hospital