Author:
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
Abstract
IntroductionA 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.MethodsWe 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 disseminationThe 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 numberNCT02603341
Funder
Patient-Centered Outcomes Research Institute
Reference65 articles.
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
2. Compensating for heterogeneities in proton radiation therapy
3. 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].
4. Systematic Review: Charged-Particle Radiation Therapy for Cancer
5. 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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