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

AbstractPrimary ObjectiveRecently, 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 CriteriaPatient 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 CriteriaIf data collection is opposed, treatment is reimbursed but not administered, or treatment is administered but not reimbursed.Outcome MeasuresPrimary 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 IncludedThis is an open study and there is no set number of patients; 115 have already been enrolled.Planned Subgroup AnalysesAnalyses 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 p...
Source: CardioVascular and Interventional Radiology - Category: Radiology Source Type: research