Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue CardioVascular and Interventional Radiology Année : 2022

Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France

Jean-Baptiste Pinaquy
  • Fonction : Auteur
Clement Bailly
Christian Sengel
  • Fonction : Auteur
Julien Edeline
Jean-Frederic Blanc
  • Fonction : Auteur
Antoine Bouvier
  • Fonction : Auteur
Jeremie Tordo
  • Fonction : Auteur
Agnes Rode
  • Fonction : Auteur
Stéphanie Becker
  • Fonction : Auteur
David Sefrioui
Thierry de Baere
Claude Somma
  • Fonction : Auteur
Charles Mastier
  • Fonction : Auteur
Jean Goupil
  • Fonction : Auteur
Patrick Chevallier
  • Fonction : Auteur
Helene Regnault
  • Fonction : Auteur
Eric Vibert
  • Fonction : Auteur
Sylvain Manfredi
  • Fonction : Auteur
Eric Vicaut
Binal Patel
  • Fonction : Auteur
Eveline Boucher
  • Fonction : Auteur

Résumé

Primary Objective: Recently, selective internal radiation therapy using yttrium-90 (Y90) glass microspheres (TheraSphere™) was approved for reimbursement by health authorities in France. The PROACTIF study aims to gather data on effectiveness, patient quality of life, and safety with use of Y90 glass microspheres in real-world clinical settings in France. Inclusion Criteria: Patient with a diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCC), and/or metastatic colorectal cancer (mCRC) who was treated with a dose of Y90 glass microspheres that has been reimbursed in France and who do not oppose use of their personal medical data. Exclusion Criteria: If data collection is opposed, treatment is reimbursed but not administered, or treatment is administered but not reimbursed. Outcome Measures: Primary outcome measures include overall survival from time of Y90 glass microsphere treatment and quality of life, as assessed using the Functional Assessment of Cancer Therapy- Hepatobiliary questionnaire. Estimated Number of Patients to Be Included This is an open study and there is no set number of patients; 115 have already been enrolled. Planned Subgroup Analyses: Analyses will be stratified by disease state (HCC, iCC, or mCRC). Subgroups to be analyzed include age group, unilobar/bilobar disease at baseline, Eastern Cooperative Oncology Group (ECOG) status at baseline, liver tumor burden at baseline, target lesion size, and standard versus multi-compartment personalized dosimetry treatment. Planned Recruitment and Observation Period: Recruitment includes patients who are prescribed and treated with a commercial vial of Y90 glass microspheres between 01 January 2019 and 31 December 2024. Trial registration: ClinicalTrials.gov Identifier: NCT04069468.
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Dates et versions

hal-03437678 , version 1 (30-06-2023)

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Etienne Garin, Jean-Baptiste Pinaquy, Clement Bailly, Christian Sengel, Denis Mariano-Goulart, et al.. Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France. CardioVascular and Interventional Radiology, 2022, 45 (1), pp.1-11. ⟨10.1007/s00270-021-03002-0⟩. ⟨hal-03437678⟩
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