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.
Cardiovasc Intervent Radiol
; 45(1): 1-11, 2022 Jan.
Article
em En
| MEDLINE
| ID: mdl-34796373
ABSTRACT
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. OUTCOMEMEASURES:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias dos Ductos Biliares
/
Neoplasias Colorretais
/
Colangiocarcinoma
/
Carcinoma Hepatocelular
/
Embolização Terapêutica
/
Neoplasias Hepáticas
Tipo de estudo:
Evaluation_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
Aspecto:
Patient_preference
Limite:
Humans
Idioma:
En
Revista:
Cardiovasc Intervent Radiol
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
França