Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol
| Autor: | Christy Kesslering, Amy Berrington de Gonzalez, Suneel Nagda, Christine D. Berg, Karen D. Schupak, Elizabeth A. Hahn, Shannon M. MacDonald, Bonnie Ky, Cynthia Chauhan, Robert W. Mutter, Alphonse G. Taghian, Hien L. Lu, Stephanie L. Pugh, Kaysee Baker, Simon N. Powell, M. Pankuch, L. Christine Fang, Justin E. Bekelman, Mark V. Mishra, Rachel B. Jimenez, Choonsik Lee, Atif J. Khan, Fred W. Prior, Gary M. Freedman, J. Ben Wilkinson, Susan S. Ellenberg, Lior Z. Braunstein, Hsiao-Ming Lu, C. Daniel Mullins, Walter R. Bosch, Oren Cahlon, Bruce G. Haffty |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
protocols & guidelines medicine.medical_treatment Breast Neoplasms breast tumours 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Breast cancer Quality of life Pragmatic Clinical Trials as Topic medicine Protocol Proton Therapy Humans Myocardial infarction Intensive care medicine Proton therapy Randomized Controlled Trials as Topic clinical trials Photons business.industry Unstable angina radiation oncology General Medicine medicine.disease Radiation therapy Clinical trial Treatment Outcome Oncology 030220 oncology & carcinogenesis Heart failure Female business |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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