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, Hien Lu, Stephanie Pugh, Kaysee Baker, Christine D. Berg, Amy Berrington De Gonzalez, Lior Z. Braunstein, Walter Bosch, Cynthia Chauhan, Susan Ellenberg, L. Christine Fang, Gary M. Freedman, Elizabeth A. Hahn, B. G. Haffty, Atif J. Khan, Rachel B. Jimenez, Christy Kesslering, Bonnie Ky, Choonsik Lee, Hsiao Ming LuMark V. Mishra, C. Daniel Mullins, Robert W. Mutter, Suneel Nagda, Mark Pankuch, Simon N. Powell, Fred W. Prior, Karen Schupak, Alphonse G. Taghian, J. Ben Wilkinson, Shannon M. Macdonald, Oren Cahlon

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article numbere025556
JournalBMJ open
Volume9
Issue number10
DOIs
StatePublished - Oct 1 2019

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Pragmatic Clinical Trials
Proton Therapy
Clinical Protocols
Photons
Protons
Radiotherapy
Randomized Controlled Trials
Breast Neoplasms
Cardiac Arrhythmias
Heart Failure
Radiation
Morbidity
Mortality
Research Ethics Committees
Unstable Angina
Therapeutics
Ethics
Publications
Hospital Emergency Service
Neoplasms

Keywords

  • breast tumours
  • clinical trials
  • protocols & guidelines
  • radiation oncology

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer : The Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol. / Bekelman, Justin E.; Lu, Hien; Pugh, Stephanie; Baker, Kaysee; Berg, Christine D.; De Gonzalez, Amy Berrington; Braunstein, Lior Z.; Bosch, Walter; Chauhan, Cynthia; Ellenberg, Susan; Fang, L. Christine; Freedman, Gary M.; Hahn, Elizabeth A.; Haffty, B. G.; Khan, Atif J.; Jimenez, Rachel B.; Kesslering, Christy; Ky, Bonnie; Lee, Choonsik; Lu, Hsiao Ming; Mishra, Mark V.; Mullins, C. Daniel; Mutter, Robert W.; Nagda, Suneel; Pankuch, Mark; Powell, Simon N.; Prior, Fred W.; Schupak, Karen; Taghian, Alphonse G.; Wilkinson, J. Ben; Macdonald, Shannon M.; Cahlon, Oren.

In: BMJ open, Vol. 9, No. 10, e025556, 01.10.2019.

Research output: Contribution to journalArticle

Bekelman, JE, Lu, H, Pugh, S, Baker, K, Berg, CD, De Gonzalez, AB, Braunstein, LZ, Bosch, W, Chauhan, C, Ellenberg, S, Fang, LC, Freedman, GM, Hahn, EA, Haffty, BG, Khan, AJ, Jimenez, RB, Kesslering, C, Ky, B, Lee, C, Lu, HM, Mishra, MV, Mullins, CD, Mutter, RW, Nagda, S, Pankuch, M, Powell, SN, Prior, FW, Schupak, K, Taghian, AG, Wilkinson, JB, Macdonald, SM & Cahlon, O 2019, 'Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: The Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol', BMJ open, vol. 9, no. 10, e025556. https://doi.org/10.1136/bmjopen-2018-025556
Bekelman, Justin E. ; Lu, Hien ; Pugh, Stephanie ; Baker, Kaysee ; Berg, Christine D. ; De Gonzalez, Amy Berrington ; Braunstein, Lior Z. ; Bosch, Walter ; Chauhan, Cynthia ; Ellenberg, Susan ; Fang, L. Christine ; Freedman, Gary M. ; Hahn, Elizabeth A. ; Haffty, B. G. ; Khan, Atif J. ; Jimenez, Rachel B. ; Kesslering, Christy ; Ky, Bonnie ; Lee, Choonsik ; Lu, Hsiao Ming ; Mishra, Mark V. ; Mullins, C. Daniel ; Mutter, Robert W. ; Nagda, Suneel ; Pankuch, Mark ; Powell, Simon N. ; Prior, Fred W. ; Schupak, Karen ; Taghian, Alphonse G. ; Wilkinson, J. Ben ; Macdonald, Shannon M. ; Cahlon, Oren. / Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer : The Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol. In: BMJ open. 2019 ; Vol. 9, No. 10.
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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.",
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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

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.

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