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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 |
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| Authors: | Garin Etienne Pinaquy Jean-Baptiste Bailly Clement Sengel Christian Mariano-Goulart Denis Edeline Julien Blanc Jean-Frederic Bouvier Antoine Tordo Jeremie Rode Agnes Becker Stéphanie Sefrioui David de Baere Thierry Somma Claude Mastier Charles Goupil Jean Chevallier Patrick Regnault Helene Vibert Eric Manfredi Sylvain Vicaut Eric Patel Binal Boucher Eveline Guiu Boris |
| Affiliation: | 1.Nuclear Medicine Unit, Centre Eugene Marquis, Rennes, France ;2.Nuclear Medicine Service, CHU Bordeaux, Bordeaux, France ;3.Nuclear Medicine Unit, University Hospital, Nantes, France ;4.Radiology and Medical Imaging, CHU Hospital Michallon, Grenoble, France ;5.Nuclear Medicine, CHU Hospital Bordeaux, Bordeaux, France ;6.Medical Oncology, Centre Eugène Marquis, Rennes, France ;7.Hepatology, Gastroenterology, and Digestive Oncology, CHU Bordeaux, Bordeaux, France ;8.Department of Radiology, University Hospital, Angers, France ;9.Department of Nuclear Medicine, CHU Lyon Sud, Lyon, France ;10.Department of Medical Imaging, CHU Lyon, Lyon, France ;11.Departments of Medical Imaging and Nuclear Medicine, Centre Henri Bequerel, Rouen, France ;12.Department of Hepatogastroenterology, Rouen University Hospital, Rouen, France ;13.Department of Interventional Radiology, Gustave Roussy Cancer Center, Villejuif, France ;14.Department of Nuclear Medicine, CHU La Timone, Marseille, France ;15.Department of Radiology, CRLCC Centre Léon Bérard, Lyon, France ;16.Department of Radiology and Medical Imaging, CHU Nimes, Nimes, France ;17.Department of Radiology, CHU Nice, Nice, France ;18.Department of Hepatology, Henri Mondor Hospital, Creteil, France ;19.Department of Hepatology and Surgery, Paul Brousse Hospital, Villejuif, France ;20.Department of Digestive Oncology, University Hospital, Dijon, France ;21.Clinical Trial Unit, AP-HP Groupe Hospitalier Lariboisière - Fernand-Widal, Paris, France ;22.Biostatistics, Boston Scientific Corporation, Marlborough, MA, USA ;23.Interventional Oncology, Boston Scientific Corporation, Marlborough, MA, USA ;24.Department of Radiology, St. Eloi University Hospital – Montpellier School of Medicine, 80 avenue Augustin Fliche, 34295, Montpellier, France ; |
| 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 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 personalized dosimetry treatment. Planned Recruitment and Observation PeriodRecruitment includes patients who are prescribed and treated with a commercial vial of Y90 glass microspheres between 01 January 2019 and 31 December 2024. Trial registrationClinicalTrials.gov Identifier: NCT04069468. |
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