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

Authors: Bekelman, J. E.; Lu, H.; Pugh, S.; Baker, K.; Berg, C. D.; De Gonzalez, A. B.; Braunstein, L. Z.; Bosch, W.; Chauhan, C.; Ellenberg, S.; Fang, L. C.; Freedman, G. M.; Hahn, E. A.; Haffty, B. G.; Khan, A. J.; Jimenez, R. B.; Kesslering, C.; Ky, B.; Lee, C.; Lu, H. M.; Mishra, M. V.; Mullins, C. D.; Mutter, R. W.; Nagda, S.; Pankuch, M.; Powell, S. N.; Prior, F. W.; Schupak, K.; Taghian, A. G.; Wilkinson, J. B.; MacDonald, S. M.; Cahlon, O.; RadComp (Radiotherapy Comparative Effectiveness Consortium)
Contributors: Cuaron, J.; Gelblum, D.; Gillespie, E.; Hong, L.; McCormick, B.; Mychalczak, B.; Parhar, P.; Romesser, P.; Shepherd, A. M.
Article Title: Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: The Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol
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. © 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.
Keywords: radiation oncology; clinical trials; breast tumours; protocols & guidelines
Journal Title: BMJ Open
Volume: 9
Issue: 10
ISSN: 2044-6055
Publisher: BMJ Publishing Group Ltd.  
Date Published: 2019-10-01
Start Page: e025556
Language: English
DOI: 10.1136/bmjopen-2018-025556
PUBMED: 31619413
PROVIDER: scopus
PMCID: PMC6797426
Notes: Article -- Export Date: 1 November 2019 -- Source: Scopus
Citation Impact
MSK Authors
  1. Simon Nicholas Powell
    193 Powell
  2. Preeti Kanwal Parhar
    15 Parhar
  3. Daphna Y Gelblum
    93 Gelblum
  4. Linda Xueqi Hong
    56 Hong
  5. Oren Cahlon
    104 Cahlon
  6. Karen D Schupak
    72 Schupak
  7. Beryl McCormick
    306 McCormick
  8. John Jacob Cuaron
    47 Cuaron
  9. Atif Jalees Khan
    41 Khan