← Back to Search

Radioactive Agent

Long-Term Effects of Radium-223 Dichloride for Cancer

Phase 4

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

Study Summary

This trial will study how well BAY88-8223 / Radium-223 dichloride / Xofigo works in treating patients who have already been treated with it.

Who is the study for?

This trial is for individuals who were previously enrolled in a specific company-sponsored study and have received at least one dose of radium-223 dichloride or placebo. There are no additional exclusion criteria since this is a follow-up study.Check my eligibility

What is being tested?

The trial isn't testing a new treatment but is collecting data from patients who have already been treated with Radium-223 dichloride, also known as Xofigo, to understand long-term effects.See study design

What are the potential side effects?

Since this study involves data collection rather than active treatment, it does not introduce new side effects. It focuses on observing any long-term outcomes from the prior use of Radium-223.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of any other new primary malignancy

Incidence of aplastic anemia

Incidence of bone fractures

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,723 Total Patients Enrolled

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,261,684 Total Patients Enrolled

Media Library

Radium-223 Dichloride (Radioactive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02312960 — Phase 4

Cancer Clinical Trial 2023: Radium-223 Dichloride Highlights & Side Effects. Trial Name: NCT02312960 — Phase 4

Radium-223 Dichloride (Radioactive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02312960 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are providing access to this clinical investigation?

"Currently, 18 separate medical centres are recruiting trial participants. These include Omaha, Toronto and Ashland in addition to 15 other sites. To reduce the burden of travel, prospective patients should select a site close to their residence."

Answered by AI

Is enrollment for this experiment presently open?

"Indeed, the trial is presently admitting patients. This study was initially registered on December 18th 2014 and has been updated as recently as November 18th 2022 according to clinicaltrials.gov's records."

Answered by AI

How many participants are being included in this research project?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial has been recruiting since December 18th 2014 and is currently open for enrollment. 800 individuals must be enrolled from a network of 18 sites across the country."

Answered by AI

Has this procedure received regulatory approval from the FDA?

"Evaluating the safety of this treatment, our experts at Power have assigned a score of 3 due to it being in Phase 4 trials and thus approved by regulatory bodies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radium-223 Dichloride Long-term Follow-up Program

2014. "Radium-223 Dichloride Long-term Follow-up Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02312960.