• Login
    View Item 
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2019
    • View Item
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2019
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Author
    Bekelman, J.E.
    Baker, K.
    RadComp (Radiotherapy Comparative Effectiveness Consortium)
    Date
    2019
    Journal
    BMJ open
    Publisher
    BMJ Publishing Group
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1136/bmjopen-2018-025556
    Abstract
    INTRODUCTION: A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer. METHODS: We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events. ETHICS AND DISSEMINATION: The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets. TRIAL REGISTRATION NUMBER: NCT02603341. Copyright Author(s) (or their employer(s)) 2019.
    Sponsors
    This work was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1403-12804).
    Keyword
    breast tumors
    clinical trials
    protocols & guidelines
    radiation oncology
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85073477676&doi=10.1136%2fbmjopen-2018-025556&partnerID=40&md5=ecd5dd1a0fbecc42397838af884149ee; http://hdl.handle.net/10713/11214
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2018-025556
    Scopus Count
    Collections
    UMB Open Access Articles 2019

    entitlement

    Related articles

    • Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial.
    • Authors: Neuman MD, Ellenberg SS, Sieber FE, Magaziner JS, Feng R, Carson JL, REGAIN Investigators.
    • Issue date: 2016 Nov 15
    • Joint Estimation of Cardiac Toxicity and Recurrence Risks After Comprehensive Nodal Photon Versus Proton Therapy for Breast Cancer.
    • Authors: Stick LB, Yu J, Maraldo MV, Aznar MC, Pedersen AN, Bentzen SM, Vogelius IR
    • Issue date: 2017 Mar 15
    • Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial.
    • Authors: Lyngbakken MN, Berdal JE, Eskesen A, Kvale D, Olsen IC, Rangberg A, Jonassen CM, Omland T, Røsjø H, Dalgard O
    • Issue date: 2020 Jun 5
    • Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.
    • Authors: Kowark A, Adam C, Ahrens J, Bajbouj M, Bollheimer C, Borowski M, Dodel R, Dolch M, Hachenberg T, Henzler D, Hildebrand F, Hilgers RD, Hoeft A, Isfort S, Kienbaum P, Knobe M, Knuefermann P, Kranke P, Laufenberg-Feldmann R, Nau C, Neuman MD, Olotu C, Rex C, Rossaint R, Sanders RD, Schmidt R, Schneider F, Siebert H, Skorning M, Spies C, Vicent O, Wappler F, Wirtz DC, Wittmann M, Zacharowski K, Zarbock A, Coburn M, iHOPE study group.
    • Issue date: 2018 Oct 18
    • Comparative Effectiveness of Proton vs Photon Therapy as Part of Concurrent Chemoradiotherapy for Locally Advanced Cancer.
    • Authors: Baumann BC, Mitra N, Harton JG, Xiao Y, Wojcieszynski AP, Gabriel PE, Zhong H, Geng H, Doucette A, Wei J, O'Dwyer PJ, Bekelman JE, Metz JM
    • Issue date: 2020 Feb 1
    DSpace software (copyright © 2002 - 2021)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.