RADTHYR: an open-label, single-arm, prospective multicenter phase II trial of Radium-223 for the treatment of bone metastases from radioactive iodine refractory differentiated thyroid cancer.
Alpha emitters
Bone metastases
Leukemia
Radium-223
Refractory thyroid cancer
Journal
European journal of nuclear medicine and molecular imaging
ISSN: 1619-7089
Titre abrégé: Eur J Nucl Med Mol Imaging
Pays: Germany
ID NLM: 101140988
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
received:
30
10
2020
accepted:
01
02
2021
pubmed:
24
2
2021
medline:
18
9
2021
entrez:
23
2
2021
Statut:
ppublish
Résumé
This is the first prospective trial evaluating the efficacy of alpha emitter Radium-223 in patients with bone metastases from radioactive iodine (RAI) refractory (RAIR) differentiated thyroid cancer. RADTHYR is a multicenter, single-arm prospective Simon two-stage phase II trial (NCT02390934). The primary objective was to establish the efficacy of three administrations of 55 kBq/kg of Radium-223 by Ten patients were enrolled between July 2015 and December 2017 (4 M; median age 74 years). Prior to Radium-223 administration, patients received a median RAI cumulative activity of 15 GBq (7.4-35.6), external radiation therapy (n = 9), bone surgery (n = 8), cimentoplasty (n = 5), and cryoablation (n = 2). The trial was stopped after interim analysis for lack of response of bone metastases from RAIR thyroid cancer to Radium-223. Severe hematological toxicity was observed in patients heavily pretreated with RAI and external radiation. NCT02390934. Registration date 18.03.2015.
Identifiants
pubmed: 33619600
doi: 10.1007/s00259-021-05229-y
pii: 10.1007/s00259-021-05229-y
pmc: PMC8426251
doi:
Substances chimiques
Iodine Radioisotopes
0
Radium-223
8BR2SOL3L1
Radium
W90AYD6R3Q
Banques de données
ClinicalTrials.gov
['NCT02390934']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
3238-3249Informations de copyright
© 2021. The Author(s).
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