Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
NCT ID:
NCT03304418
Group ID:
EG000
Title:
Radium Ra 223 Dichloride and Radiation, All Patients
Description:
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)
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
20
Other Number Affected:
20
Other Number At Risk:
20
Study:
NCT03304418
Results Section:
NCT03304418
Adverse Events Module:
NCT03304418