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. 2024 Mar 12;24(1):333.
doi: 10.1186/s12885-024-12059-2.

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

Daniela Alterio  1 , Maria Giulia Vincini  2 , Stefania Volpe  1   3 , Luca Bergamaschi  1 , Mattia Zaffaroni  1 , Sara Gandini  4 , Giulia Peruzzotti  5 , Federica Cattani  6 , Cristina Garibaldi  7 , Barbara Alicja Jereczek-Fossa #  1   3 , Roberto Orecchia #  8
Affiliations

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

Daniela Alterio et al. BMC Cancer. .

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.

Keywords: High-quality dataset; Hypofractionation; Proton therapy; Registry.

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Conflict of interest statement

Division of Radiotherapy IEO received research funding from AIRC (Italian Association for Cancer Research) and Fondazione IEO-CCM (Istituto Europeo di Oncologia-Centro Cardiologico Monzino) (all outside the current project). BAJF received speakers fee from Roche, Bayer, Janssen, Carl Zeiss, Ipsen, Accuray, Astellas, Elekta, IBA, Astra Zeneca (all outside the current project). MGV was supported by a research fellowship from AIRC entitled “Radioablation ± hormonotherapy for prostate cancer oligorecurrences (RADIOSA trial): potential of imaging and biology”, registered at ClinicalTrials.gov NCT03940235, approved by the Ethics Committee of IRCCS Istituto Europeo di Oncologia and Centro Cardiologico Monzino (IEO-997). IEO, the European Institute of Oncology IRCCS, was partially supported by by institutional grants from Accuray Inc. and IBA (Ion Beam Applications, Louvain-la-Neuve, Belgium). The sponsors did not play any role in the study design, collection, analysis and interpretation of data, nor in the writing of the manuscript, nor in the decision to submit the manuscript for publication. The remaining authors declare no conflict of interest that are relevant to the content of this article.

Figures

Fig. 1
Fig. 1
A schematic representation of data collected in the platform
See this image and copyright information in PMC

References

    1. Santos A, Penfold S, Gorayski P, Le eH. «The Role of Hypofractionation in Proton Therapy», Cancers, vol. 14, fasc. 9, Art. fasc. 9, gen. 2022, 10.3390/cancers14092271. - PMC - PubMed
    1. Alterio D et al. apr., «Hypofractionated proton therapy in breast cancer: where are we? A critical review of the literature», Breast Cancer Res. Treat, vol. 192, fasc. 2, pp. 249–263, 2022, 10.1007/s10549-022-06516-4. - PubMed
    1. Hoppe BS, et al. «Chemoradiation with Hypofractionated Proton Therapy in Stage II-III Non-small Cell Lung Cancer: a YYY phase 1/2 Trial». Int J Radiat Oncol. mar. 2022;0360301622002383:S. 10.1016/j.ijrobp.2022.03.005. - PubMed
    1. Volpe S, et al. «Hypofractionated proton therapy for non-small cell lung cancer: ready for prime time? A systematic review and meta-analysis». Cancer Treat Rev. nov. 2022;110:102464. 10.1016/j.ctrv.2022.102464. - PubMed
    1. Nakajima K et al. «Patient-Reported Quality of Life Outcomes after Moderately Hypofractionated and Normofractionated Proton Therapy for Localized Prostate Cancer», Cancers, vol. 14, fasc. 3, p. 517, gen. 2022, 10.3390/cancers14030517. - PMC - PubMed