- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516707
Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO (XOFIGO)
Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.
bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
Study Overview
Status
Intervention / Treatment
Detailed Description
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases.
They frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
There is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
This treatment appears to have fewer side effects than chemotherapy (and does not call into question subsequent chemotherapy) or that the currently available metabolic bone radiotherapy as well as better pain control and survival gain than the latter do not
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bordeaux, France
- ICO Bordeaux
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Clermont-Ferrand, France
- UP Clermont Ferrand
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Grenoble, France
- CHU Grenoble
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Marseille, France
- IPC Marseille
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Nantes, France
- CRLC de Nantes
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Paris, France
- APHP Hôpital Cochin
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Toulouse, France
- ONCOLOPE
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Herault
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Montpellier, Herault, France, 34298
- ICM Val d'Aurelle
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
Exclusion Criteria:
Patients expressing a refusal to use this research data
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the epidemiological characteristics of the treated patient population
Time Frame: during the treatment of XOFIGO an average of 24 weeks
|
clinical data collection in the medical record
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during the treatment of XOFIGO an average of 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment
Time Frame: during the treatment of XOFIGO an average of 24 weeks
|
clinical data collection in the medical record
|
during the treatment of XOFIGO an average of 24 weeks
|
Assess the number of patients who were able to benefit from the complete treatment (6 cycles)
Time Frame: during the treatment of XOFIGO an average of 24 weeks
|
clinical data collection in the medical record
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during the treatment of XOFIGO an average of 24 weeks
|
Collect the causes of premature discontinuation of treatment
Time Frame: during the treatment of XOFIGO an average of 24 weeks
|
clinical data collection in the medical record
|
during the treatment of XOFIGO an average of 24 weeks
|
assess the antalgic effet of treatment (number of antalgic taken and how many time)
Time Frame: during the treatment of XOFIGO an average of 24 weeks
|
clinical data collection in the medical record
|
during the treatment of XOFIGO an average of 24 weeks
|
assess the overall survival
Time Frame: during the treatment of XOFIGO an average of 24 weeks
|
clinical data collection in the medical record
|
during the treatment of XOFIGO an average of 24 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Emmanuel DESHAYES, MD, ICM Val d'Aurelle
Publications and helpful links
General Publications
- Harrison MR, Wong TZ, Armstrong AJ, George DJ. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5:1-14. doi: 10.2147/CMAR.S25537. Epub 2013 Jan 8.
- Nilsson S, Strang P, Aksnes AK, Franzen L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland OS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15.
- Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germa JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICM-URC 2015/75
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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