Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO
NCT ID: NCT04516707
Last Updated: 2020-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
67 participants
OBSERVATIONAL
2016-01-01
2018-05-01
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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clinical database
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All data collected to create the database for this project will be anonymized
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Emmanuel DESHAYES, MD
Role: STUDY_CHAIR
ICM Val d'Aurelle
Locations
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Icm Val D'Aurelle
Montpellier, Herault, France
ICO Bordeaux
Bordeaux, , France
UP Clermont Ferrand
Clermont-Ferrand, , France
Chu Grenoble
Grenoble, , France
IPC Marseille
Marseille, , France
CRLC de Nantes
Nantes, , France
APHP Hopital Cochin
Paris, , France
ONCOLOPE
Toulouse, , France
Countries
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References
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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.
Other Identifiers
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ICM-URC 2015/75
Identifier Type: -
Identifier Source: org_study_id
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