{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T00:45:02Z","timestamp":1710290702657},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T00:00:00Z","timestamp":1710201600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T00:00:00Z","timestamp":1710201600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Cancer"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>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 <jats:italic>POWER<\/jats:italic> 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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\u00aeONE or Proteus\u00aePLUS 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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12885-024-12059-2","type":"journal-article","created":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T18:02:11Z","timestamp":1710266531000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A multicenter high-quality data registry for advanced proton therapy approaches: the POWER registry"],"prefix":"10.1186","volume":"24","author":[{"given":"Daniela","family":"Alterio","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Giulia","family":"Vincini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefania","family":"Volpe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luca","family":"Bergamaschi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mattia","family":"Zaffaroni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Gandini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giulia","family":"Peruzzotti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Federica","family":"Cattani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Garibaldi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara Alicja","family":"Jereczek-Fossa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Orecchia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,3,12]]},"reference":[{"key":"12059_CR1","doi-asserted-by":"publisher","unstructured":"Santos A, Penfold S, Gorayski P, Le eH. \u00abThe Role of Hypofractionation in Proton Therapy\u00bb, Cancers, vol. 14, fasc. 9, Art. fasc. 9, gen. 2022, https:\/\/doi.org\/10.3390\/cancers14092271.","DOI":"10.3390\/cancers14092271"},{"key":"12059_CR2","doi-asserted-by":"publisher","unstructured":"Alterio D et al. apr., \u00abHypofractionated proton therapy in breast cancer: where are we? A critical review of the literature\u00bb, Breast Cancer Res. Treat, vol. 192, fasc. 2, pp. 249\u2013263, 2022, https:\/\/doi.org\/10.1007\/s10549-022-06516-4.","DOI":"10.1007\/s10549-022-06516-4"},{"key":"12059_CR3","doi-asserted-by":"publisher","unstructured":"Hoppe BS, et al. \u00abChemoradiation with Hypofractionated Proton Therapy in Stage II-III Non-small Cell Lung Cancer: a YYY phase 1\/2 Trial\u00bb. Int J Radiat Oncol. mar. 2022;0360301622002383:S. https:\/\/doi.org\/10.1016\/j.ijrobp.2022.03.005.","DOI":"10.1016\/j.ijrobp.2022.03.005"},{"key":"12059_CR4","doi-asserted-by":"publisher","unstructured":"Volpe S, et al. \u00abHypofractionated proton therapy for non-small cell lung cancer: ready for prime time? A systematic review and meta-analysis\u00bb. Cancer Treat Rev. nov. 2022;110:102464. https:\/\/doi.org\/10.1016\/j.ctrv.2022.102464.","DOI":"10.1016\/j.ctrv.2022.102464"},{"key":"12059_CR5","doi-asserted-by":"publisher","unstructured":"Nakajima K et al. \u00abPatient-Reported Quality of Life Outcomes after Moderately Hypofractionated and Normofractionated Proton Therapy for Localized Prostate Cancer\u00bb, Cancers, vol. 14, fasc. 3, p. 517, gen. 2022, https:\/\/doi.org\/10.3390\/cancers14030517.","DOI":"10.3390\/cancers14030517"},{"key":"12059_CR6","doi-asserted-by":"publisher","unstructured":"Parzen JS et al. \u00abHypofractionated proton beam radiotherapy in patients with unresectable liver tumors: multi-institutional prospective results from the Proton Collaborative Group\u00bb, Radiat. Oncol, vol. 15, fasc. 1, p. 255, dic. 2020, https:\/\/doi.org\/10.1186\/s13014-020-01703-3.","DOI":"10.1186\/s13014-020-01703-3"},{"key":"12059_CR7","doi-asserted-by":"publisher","unstructured":"Poon DMC, Wu S, Ho L, Cheung KY, Yu eB. \u00abProton Therapy for Prostate Cancer: Challenges and Opportunities\u00bb, Cancers, vol. 14, fasc. 4, p. 925, feb. 2022, https:\/\/doi.org\/10.3390\/cancers14040925.","DOI":"10.3390\/cancers14040925"},{"key":"12059_CR8","unstructured":"14:00\u201317:00, \u00abISO 14155:2020\u00bb, ISO. Consultato: 2 febbraio 2023. [Online]. Disponibile su: https:\/\/www.iso.org\/standard\/71690.html."},{"key":"12059_CR9","doi-asserted-by":"publisher","unstructured":"Eisenhauer EA et al. \u00abNew response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)\u00bb, Eur. J. Cancer, vol. 45, fasc. 2, pp. 228\u2013247, gen. 2009, https:\/\/doi.org\/10.1016\/j.ejca.2008.10.026.","DOI":"10.1016\/j.ejca.2008.10.026"},{"key":"12059_CR10","doi-asserted-by":"publisher","unstructured":"Wen PY et al. apr., \u00abUpdated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Working Group\u00bb, J. Clin. 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Oncol, vol. 75, fasc. 2, pp. 489\u2013496, ott. 2009, https:\/\/doi.org\/10.1016\/j.ijrobp.2009.06.014.","DOI":"10.1016\/j.ijrobp.2009.06.014"},{"key":"12059_CR14","doi-asserted-by":"publisher","unstructured":"Scott JG et al. feb., \u00abA genome-based model for adjusting radiotherapy dose (GARD): a retrospective, cohort-based study\u00bb, Lancet Oncol, vol. 18, fasc. 2, pp. 202\u2013211, 2017, https:\/\/doi.org\/10.1016\/S1470-2045(16)30648-9.","DOI":"10.1016\/S1470-2045(16)30648-9"},{"key":"12059_CR15","doi-asserted-by":"publisher","unstructured":"Whelan TJ et al. feb., \u00abLong-Term Results of Hypofractionated Radiation Therapy for Breast Cancer\u00bb, N. Engl. J. Med, vol. 362, fasc. 6, pp. 513\u2013520, 2010, https:\/\/doi.org\/10.1056\/NEJMoa0906260.","DOI":"10.1056\/NEJMoa0906260"},{"key":"12059_CR16","doi-asserted-by":"publisher","unstructured":"Aluwini S et al. apr., \u00abHypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): late toxicity results from a randomised, non-inferiority, phase 3 trial\u00bb, Lancet Oncol, vol. 17, fasc. 4, pp. 464\u2013474, 2016, https:\/\/doi.org\/10.1016\/S1470-2045(15)00567-7.","DOI":"10.1016\/S1470-2045(15)00567-7"},{"key":"12059_CR17","doi-asserted-by":"publisher","unstructured":"Aluwini S et al. mar., \u00abHypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): acute toxicity results from a randomised non-inferiority phase 3 trial\u00bb, Lancet Oncol, vol. 16, fasc. 3, pp. 274\u2013283, 2015, https:\/\/doi.org\/10.1016\/S1470-2045(14)70482-6.","DOI":"10.1016\/S1470-2045(14)70482-6"},{"key":"12059_CR18","doi-asserted-by":"publisher","unstructured":"Delaney G, Jacob S, Featherstone C, Barton eM. \u00abThe role of radiotherapy in cancer treatment: Estimating optimal utilization from a review of evidence-based clinical guidelines\u00bb, Cancer, vol. 104, fasc. 6, pp. 1129\u20131137, set. 2005, https:\/\/doi.org\/10.1002\/cncr.21324.","DOI":"10.1002\/cncr.21324"},{"key":"12059_CR19","unstructured":"\u00abPTCOG - Facilities in Operation\u00bb. Consultato: 3 gennaio 2023. [Online]. Disponibile su: https:\/\/www.ptcog.ch\/index.php\/facilities-in-operation-restricted."},{"key":"12059_CR20","doi-asserted-by":"publisher","unstructured":"Friedrich T. \u00abProton RBE dependence on dose in the setting of hypofractionation\u00bb, Br. J. Radiol, vol. 93, fasc. 1107, p. 20190291, mar. 2020, https:\/\/doi.org\/10.1259\/bjr.20190291.","DOI":"10.1259\/bjr.20190291"},{"key":"12059_CR21","doi-asserted-by":"publisher","unstructured":"Paganetti H. \u00abRelative biological effectiveness (RBE) values for proton beam therapy. Variations as a function of biological endpoint, dose, and linear energy transfer\u00bb, Phys. Med. Biol, vol. 59, fasc. 22, pp. R419-472, nov. 2014, https:\/\/doi.org\/10.1088\/0031-9155\/59\/22\/R419.","DOI":"10.1088\/0031-9155\/59\/22\/R419"},{"key":"12059_CR22","unstructured":"European Organisation for Research and Treatment of Cancer - EORTC, \u00abE2-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe\u00bb, clinicaltrials.gov, Clinical trial registration NCT03818503., nov. 2019. Consultato: 16 gennaio 2023. [Online]. Disponibile su: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03818503."},{"key":"12059_CR23","unstructured":"Fr\u00e9d\u00e9ric \u00abCohorts\u00bb, E2-RADIatE. Consultato: 17 gennaio 2023. [Online]. Disponibile su: https:\/\/project.eortc.org\/e2-radiate\/cohorts\/."},{"key":"12059_CR24","unstructured":"\u00abUse case.: PROTRAIT, national registration of proton therapy data| The Personal Health Train\u00bb. Consultato: 2 febbraio 2023. [Online]. Disponibile su: https:\/\/pht.health-ri.nl\/use-cases\/health-research\/use-case-protrait-national-registration-proton-therapy-data."},{"key":"12059_CR25","doi-asserted-by":"publisher","unstructured":"Botticelli A et al. nov., \u00abReal-World Outcomes of Trastuzumab Deruxtecan in Patients With HER2\u2009+\u2009Metastatic Breast Cancer: The DE-REAL Study\u00bb, The Oncologist, p. oyad308, 2023, https:\/\/doi.org\/10.1093\/oncolo\/oyad308.","DOI":"10.1093\/oncolo\/oyad308"}],"container-title":["BMC Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12885-024-12059-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12885-024-12059-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12885-024-12059-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T18:02:27Z","timestamp":1710266547000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmccancer.biomedcentral.com\/articles\/10.1186\/s12885-024-12059-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,12]]},"references-count":25,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["12059"],"URL":"https:\/\/doi.org\/10.1186\/s12885-024-12059-2","relation":{},"ISSN":["1471-2407"],"issn-type":[{"value":"1471-2407","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,12]]},"assertion":[{"value":"18 July 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 March 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All procedures performed in the present study involving human participants will be in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors. This study has been approved by the Institutional Scientific Board of the European Institute of Oncology (IEO) following a notification to the IEO Ethics Committee (identification number n. R1760722-IEO 1885), and prior to the patient\u2019s enrolment in the present registry written informed consent will be required for each subject.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"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 \u201cRadioablation \u00b1 hormonotherapy for prostate cancer oligorecurrences (RADIOSA trial): potential of imaging and biology\u201d, 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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"333"}}