Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study.
hepatocellular carcinoma
liver
metastasis
observational study
radioisotope brachytherapy
registries
therapeutic embolization
yttrium-90
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
22 Apr 2020
22 Apr 2020
Historique:
received:
17
09
2019
accepted:
21
02
2020
revised:
30
01
2020
entrez:
23
4
2020
pubmed:
23
4
2020
medline:
23
4
2020
Statut:
epublish
Résumé
Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life. Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020. The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes. ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459. DERR1-10.2196/16296.
Sections du résumé
BACKGROUND
BACKGROUND
Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking.
OBJECTIVE
OBJECTIVE
The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting.
METHODS
METHODS
Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life.
RESULTS
RESULTS
Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020.
CONCLUSIONS
CONCLUSIONS
The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/16296.
Identifiants
pubmed: 32319960
pii: v9i4e16296
doi: 10.2196/16296
pmc: PMC7203613
doi:
Banques de données
ClinicalTrials.gov
['NCT02305459']
Types de publication
Journal Article
Langues
eng
Pagination
e16296Informations de copyright
©Thomas Helmberger, Dirk Arnold, José I Bilbao, Niels de Jong, Geert Maleux, Anders Nordlund, Bora Peynircioglu, Bruno Sangro, Ricky A Sharma, Agnes Walk. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.04.2020.
Références
Hepatobiliary Surg Nutr. 2018 Dec;7(6):487-489
pubmed: 30652096
World J Gastroenterol. 2015 Jul 21;21(27):8271-83
pubmed: 26217079
Lancet Oncol. 2017 Dec;18(12):1624-1636
pubmed: 29107679
Oncotarget. 2016 Aug 23;7(34):55368-55376
pubmed: 27421135
Cardiovasc Intervent Radiol. 2012 Oct;35(5):1066-73
pubmed: 21800231
J Hepatol. 2012 Apr;56(4):908-43
pubmed: 22424438
Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33
pubmed: 11858978
Int J Cancer. 2019 Apr 15;144(8):1941-1953
pubmed: 30350310
J Clin Oncol. 2016 May 20;34(15):1723-31
pubmed: 26903575
Qual Life Res. 2006 Aug;15(6):1103-15; discussion 1117-20
pubmed: 16900290
Clin Oncol (R Coll Radiol). 2019 Jan;31(1):58-66
pubmed: 30297164
Gastroenterology. 2011 Feb;140(2):497-507.e2
pubmed: 21044630
J Hepatol. 2013 Mar;58(3):593-608
pubmed: 23419824
JMIR Res Protoc. 2017 Feb 15;6(2):e17
pubmed: 28202430
J Vasc Interv Radiol. 2012 Jan;23(1):96-105
pubmed: 22079516
J Clin Oncol. 2010 Aug 10;28(23):3687-94
pubmed: 20567019
JMIR Res Protoc. 2018 Aug 15;7(8):e11234
pubmed: 30111528
Eur J Nucl Med Mol Imaging. 2011 Jul;38(7):1393-406
pubmed: 21494856
Eur J Cancer. 2004 Nov;40(16):2439-44
pubmed: 15519517
Qual Life Res. 2013 Aug;22(6):1483-90
pubmed: 23054491
Hepatology. 2014 May;59(5):1864-73
pubmed: 24259442
Ann Oncol. 2016 Sep;27(suppl 5):v28-v37
pubmed: 27664259
Eur J Nucl Med Mol Imaging. 2016 Jul;43(8):1425-31
pubmed: 26631239
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Eur J Cancer Care (Engl). 2008 Jan;17(1):98-104
pubmed: 18181898
J Hepatol. 2018 Jul;69(1):182-236
pubmed: 29628281
J Vasc Interv Radiol. 2019 Aug;30(8):1185-1192
pubmed: 31255499
Gastroenterology. 2016 Dec;151(6):1155-1163.e2
pubmed: 27575820
Clin Gastroenterol Hepatol. 2013 Oct;11(10):1358-1365.e1
pubmed: 23644386
Lancet Oncol. 2017 Sep;18(9):1159-1171
pubmed: 28781171
Ann Oncol. 2016 Aug;27(8):1386-422
pubmed: 27380959
JMIR Res Protoc. 2019 Jan 17;8(1):e11545
pubmed: 30664496
Cardiovasc Intervent Radiol. 2013 Jun;36(3):613-22
pubmed: 23511991