Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol. Issue 10 (15th October 2019)

• Record Type: Journal Article
• Authors: 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;
• Other Names: author non-byline.; Gierga David author non-byline.; Paganetti Harald author non-byline.; Soto Daniel author non-byline.; Anand Aman author non-byline.; Halyard Michele author non-byline.; McGee Lisa A. author non-byline.; Corbin Kimberly author non-byline.; Remmes Nicholas author non-byline.; Yan Elizabeth author non-byline.; Bloom Elizabeth S. author non-byline.; Hoffman Karen E. author non-byline.; Poenisch Falk author non-byline.; Smith Benjamin author non-byline.; Zhu Xiaorong Ronald author non-byline.; Cuaron John author non-byline.; Gelblum Daphna author non-byline.; Gillespie Erin author non-byline.; Hong Linda author non-byline.; McCormick Beryl author non-byline.; Mychalczak Borys author non-byline.; Parhar Preeti author non-byline.; Romesser Paul author non-byline.; Shepherd Anne Marie author non-byline.; Bennouna Jaffa author non-byline.; Fagundes Marcio author non-byline.; Gutierrez Alonso author non-byline.; Yu Jennifer author non-byline.; Cella David author non-byline.; Mihalcik Stephen author non-byline.; Stutz Michael author non-byline.; Dvorak Tomas author non-byline.; Zeidan Omar author non-byline.; Fourkal Eugene author non-byline.; Weksberg David C. author non-byline.; Mah Dennis author non-byline.; Tsai Henry author non-byline.; Campbell Jeffrey author non-byline.; Prabhu Kiran author non-byline.; Twyford Trevor author non-byline.; Meek Allen author non-byline.; Schreuder Niek author non-byline.; Goyal Sharad author non-byline.; Millevoi Rihan author non-byline.; Ohri Nisha author non-byline.; Chang Chang author non-byline.; Sturgeon Jared author non-byline.; Bennet William author non-byline.; Tarbox Lawrence author non-byline.; Mayadev Jyoti author non-byline.; Moiseenko Vitali author non-byline.; Rash Dominique author non-byline.; Urbanic James author non-byline.; Yashar Catheryn author non-byline.; Bradley Julie A. author non-byline.; Liang Xiaoying author non-byline.; Mendenhall Nancy author non-byline.; Rutenberg Michael author non-byline.; Cheng Chee-Wai author non-byline.; Lyons Janice author non-byline.; Langen Katja author non-byline.; Nichols Elizabeth author non-byline.; Berman Abigail author non-byline.; Feigenberg Steven author non-byline.; Volker James author non-byline.; Lin Lilie author non-byline.; Nagda Suneel author non-byline.; Siegal Ann Marie author non-byline.; Taunk Neil author non-byline.; Wong Tony author non-byline.; Music Sasa author non-byline.; Straube William author non-byline.; Zoberi Imran author non-byline.; Chen Peter author non-byline.; Ding Xuanfeng author non-byline.; Dang Phuong Daniella author non-byline.; Katz Sanford author non-byline.; Rosen Lane R author non-byline.; Wu Terry author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 10(2019)
• Publication Date: 2019-10-15
• Subjects: radiation oncology -- clinical trials -- protocols & guidelines -- breast tumours; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-025556
• Languages: English
• ISSNs: 2044-6055

Abstract

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