TY - JOUR
T1 - Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer
T2 - The Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol
AU - Bekelman, Justin E.
AU - Lu, Hien
AU - Pugh, Stephanie
AU - Baker, Kaysee
AU - Berg, Christine D.
AU - De Gonzalez, Amy Berrington
AU - Braunstein, Lior Z.
AU - Bosch, Walter
AU - Chauhan, Cynthia
AU - Ellenberg, Susan
AU - Fang, L. Christine
AU - Freedman, Gary M.
AU - Hahn, Elizabeth A.
AU - Haffty, B. G.
AU - Khan, Atif J.
AU - Jimenez, Rachel B.
AU - Kesslering, Christy
AU - Ky, Bonnie
AU - Lee, Choonsik
AU - Lu, Hsiao Ming
AU - Mishra, Mark V.
AU - Mullins, C. Daniel
AU - Mutter, Robert W.
AU - Nagda, Suneel
AU - Pankuch, Mark
AU - Powell, Simon N.
AU - Prior, Fred W.
AU - Schupak, Karen
AU - Taghian, Alphonse G.
AU - Wilkinson, J. Ben
AU - Macdonald, Shannon M.
AU - Cahlon, Oren
N1 - Funding Information:
In discussion with the stakeholder advisory committee, we included an item to assess overall financial burden. This item is part of the European Organization for Research and Treatment of Cancer QLQ-C30 instrument: ‘Has your physical condition or medical treatment caused you financial difficulties?’ (not at all, a little bit, quite a bit, very much).52
Funding Information:
1Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA 2American College of Radiology, Philadelphia, Pennsylvania, USA 3Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA 4Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA 5Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA 6Department of Radiation Oncology, Washington University in St. Louis, St. Louis, Missouri, USA 7Mayo Clinic Minnesota, Rochester, Minnesota, USA 8Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA 9Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington, USA 10Department of Medical Social Sciences, Northwestern University, Evanston, Illinois, USA 11Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA 12Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA 13Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA 14Cardio-Oncology Program, Division of Cardiovascular Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA 15PHSR, University of Maryland School of Pharmacy, Baltimore, Maryland, USA 16Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA 17Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA 18Provision Proton Therapy Center, Knoxville, Tennessee, USA
Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - 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.
AB - 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.
KW - breast tumours
KW - clinical trials
KW - protocols & guidelines
KW - radiation oncology
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U2 - 10.1136/bmjopen-2018-025556
DO - 10.1136/bmjopen-2018-025556
M3 - Article
C2 - 31619413
AN - SCOPUS:85073477676
VL - 9
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 10
M1 - e025556
ER -
