Prospective data registration and clinical trials for particle therapy in Europe.

Langendijk, Johannes A; Orecchia, Roberto; Haustermans, Karin; Zips, Daniel; Balosso, Jacques; Lacombe, Denis; Lievens, Yolande; Weber, Damien Charles; Grau, Cai; Troost, Esther G C (2018). Prospective data registration and clinical trials for particle therapy in Europe. Radiotherapy and oncology, 128(1), pp. 9-13. Elsevier 10.1016/j.radonc.2018.06.001

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The overarching aim of work package 1 of the European Proton Therapy Network (EPTN) is to create a firm basis for evidence-based particle therapy at the European level. To achieve this, this work package will set up a worldwide unique prospective data registration programme for nine different tumour sites. Such programme will provide more insights into the current practice across all European particle therapy centres and into the results of particle therapy with regard to radiation-induced toxicity and efficacy in terms of local control and survival. More importantly, prospective data registration provides major opportunities to continuously improve the quality of particle therapy, by defining bench marks, to identify best practices that may learn others to improve quality of particle therapy, to synchronize selection criteria and to create more homogeneous patient cohorts to evaluate results, which is particularly important in rare tumours. This will be supported by EORTC through existing and new IT-infrastructure for data collection in different formats next to QA-platforms. In addition, work package 1 will define the requirements for high quality clinical trials in order to enhance high quality clinical trial proposals and determine alternative methods for RCT, such as the model-based approach.

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