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Open Access 01-12-2024 | Study Protocol

A multicenter high-quality data registry for advanced proton therapy approaches: the POWER registry

Authors: Daniela Alterio, Maria Giulia Vincini, Stefania Volpe, Luca Bergamaschi, Mattia Zaffaroni, Sara Gandini, Giulia Peruzzotti, Federica Cattani, Cristina Garibaldi, Barbara Alicja Jereczek-Fossa, Roberto Orecchia

Published in: BMC Cancer | Issue 1/2024

Abstract

Background

Paucity and low evidence-level data on proton therapy (PT) represent one of the main issues for the establishment of solid indications in the PT setting. Aim of the present registry, the POWER registry, is to provide a tool for systematic, prospective, harmonized, and multidimensional high-quality data collection to promote knowledge in the field of PT with a particular focus on the use of hypofractionation.

Methods

All patients with any type of oncologic disease (benign and malignant disease) eligible for PT at the European Institute of Oncology (IEO), Milan, Italy, will be included in the present registry. Three levels of data collection will be implemented: Level (1) clinical research (patients outcome and toxicity, quality of life, and cost/effectiveness analysis); Level (2) radiological and radiobiological research (radiomic and dosiomic analysis, as well as biological modeling); Level (3) biological and translational research (biological biomarkers and genomic data analysis). Endpoints and outcome measures of hypofractionation schedules will be evaluated in terms of either Treatment Efficacy (tumor response rate, time to progression/percentages of survivors/median survival, clinical, biological, and radiological biomarkers changes, identified as surrogate endpoints of cancer survival/response to treatment) and Toxicity. The study protocol has been approved by the IEO Ethical Committee (IEO 1885). Other than patients treated at IEO, additional PT facilities (equipped with Proteus®ONE or Proteus®PLUS technologies by IBA, Ion Beam Applications, Louvain-la-Neuve, Belgium) are planned to join the registry data collection. Moreover, the registry will be also fully integrated into international PT data collection networks.

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Title: A multicenter high-quality data registry for advanced proton therapy approaches: the POWER registry
Authors: Daniela Alterio
Maria Giulia Vincini
Stefania Volpe
Luca Bergamaschi
Mattia Zaffaroni
Sara Gandini
Giulia Peruzzotti
Federica Cattani
Cristina Garibaldi
Barbara Alicja Jereczek-Fossa
Roberto Orecchia
Publication date: 01-12-2024
Publisher: BioMed Central
Published in: BMC Cancer / Issue 1/2024
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-024-12059-2

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