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Comparative Study
. 2019 Oct 15;9(10):e025556.
doi: 10.1136/bmjopen-2018-025556.

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

Justin E Bekelman  1 , Hien Lu  2 , Stephanie Pugh  3 , Kaysee Baker  4 , Christine D Berg  5 , Amy Berrington de González  5 , Lior Z Braunstein  6 , Walter Bosch  7 , Cynthia Chauhan  8 , Susan Ellenberg  9 , L Christine Fang  10 , Gary M Freedman  2 , Elizabeth A Hahn  11 , B G Haffty  12 , Atif J Khan  6 , Rachel B Jimenez  13 , Christy Kesslering  14 , Bonnie Ky  15 , Choonsik Lee  5 , Hsiao-Ming Lu  13 , Mark V Mishra  4 , C Daniel Mullins  16 , Robert W Mutter  17 , Suneel Nagda  2 , Mark Pankuch  14 , Simon N Powell  6 , Fred W Prior  18 , Karen Schupak  6 , Alphonse G Taghian  13 , J Ben Wilkinson  19 , Shannon M MacDonald  13 , Oren Cahlon  6 ; RadComp (Radiotherapy Comparative Effectiveness Consortium)
Collaborators, Affiliations
Comparative Study

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

Justin E Bekelman et al. BMJ Open. .

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.

Keywords: breast tumours; clinical trials; protocols & guidelines; radiation oncology.

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Conflict of interest statement

Competing interests: JEB, SE, CDM and BK report grants from PCORI, during the conduct of the study. SNP, WB, L-MF, BGH, CK, MVM, RWM, FWP, SMM and OC report grants from University of Pennsylvania subcontracts as study investigator, during the conduct of the study.

Figures

Figure 1
Figure 1
Conceptual framework for randomised pragmatic clinical trial of proton versus photon therapy for locally advanced breast: generating patient centric, real-word evidence.
Figure 2
Figure 2
Study stratification schema.
See this image and copyright information in PMC

References

    1. Ollendorf DA, Colby J. Proton beam therapy: ICER final evidence report Washington State Health Technology Assessment Program; 2014. http://www.hca.wa.gov/hta/Documents
    1. Urie M, Goitein M, Wagner M. Compensating for heterogeneities in proton radiation therapy. Phys Med Biol 1984;29:553–66. 10.1088/0031-9155/29/5/008 - DOI - PubMed
    1. National Academies Initial national priorities for comparative effectiveness research: report brief, 2009. Available: https://www.nap.edu/read/12648/chapter/1 [Accessed 5 Sep 2017].
    1. Terasawa T, Dvorak T, Ip S, et al. Systematic review: charged-particle radiation therapy for cancer. Ann Intern Med 2009;151:556–65. 10.7326/0003-4819-151-8-200910200-00145 - DOI - PubMed
    1. Moya del Pina B, NCI Cancer Bulliten . Proton therapy for cancer: a new technology brief, 2009. Available: http://www.cancer.gov/ncicancerbulletin/090809/page8 [Accessed 12 Nov 2009].

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