20
Participants
Start Date
February 27, 2018
Primary Completion Date
September 30, 2022
Study Completion Date
August 31, 2023
Radium Ra 223 Dichloride
Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation
"All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.~Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:~* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)~* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)~* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.~* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)"
Huntsman Cancer Institute, Salt Lake City
Collaborators (1)
Bayer
INDUSTRY
University of Utah
OTHER