Purpose: Although radiotherapy is a cornerstone of multidisciplinary cancer care, radiation oncology research represents only a small proportion of the oncology research portfolio. Several factors intrinsic to radiotherapy, such as the incremental nature of technological advances, the reliance on long-term clinical endpoints, or the substantial upfront investments required to investigate innovative radiotherapy technologies, pose challenges to conducting randomized controlled trials. Alternative, blended approaches to evidence generation are therefore required to assess the breadth of radiotherapy innovations. Methods: The European Society for Radiotherapy and Oncology and the European Organisation for Research and Treatment of Cancer launched E2-RADIatE (EORTC-ESTRO RADiotherapy Infrastructure for Europe; EORTC 1811 - NCT03818503) in 2019. This pragmatic, observational, prospective multi-cohort study uses a centralised database to collect real-world data on cancer patients, their radiotherapy treatments, and outcomes across Europe. It aims to generate evidence and new hypotheses to assess radiotherapy innovations. Results: After five years, two cohorts (OligoCare and ReCare) are actively recruiting patients. The platform has enabled the generation of new research hypotheses and the testing of innovative methodological strategies with the opening of the first international oncology Trial Within Cohorts (TWiCs). Engagement of the international radiotherapy community has been central to the development and sustainability of the infrastructure, while several barriers and limitations inherent to this type of real-world research have also been identified. Conclusion: The five-year experience of E2-RADIatE demonstrates the feasibility and added value of a large-scale, prospective, real-world, multi-cohort infrastructure to support evidence generation in radiotherapy, while highlighting regulatory and methodological challenges that must be addressed to maximise impact.
Leveraging the potential of prospective registries for radiation oncology research: 5-year experience from the EORTC-ESTRO radiotherapy infrastructure for Europe (E2-RADIatE) project
Ricardi, Umberto;
2026-01-01
Abstract
Purpose: Although radiotherapy is a cornerstone of multidisciplinary cancer care, radiation oncology research represents only a small proportion of the oncology research portfolio. Several factors intrinsic to radiotherapy, such as the incremental nature of technological advances, the reliance on long-term clinical endpoints, or the substantial upfront investments required to investigate innovative radiotherapy technologies, pose challenges to conducting randomized controlled trials. Alternative, blended approaches to evidence generation are therefore required to assess the breadth of radiotherapy innovations. Methods: The European Society for Radiotherapy and Oncology and the European Organisation for Research and Treatment of Cancer launched E2-RADIatE (EORTC-ESTRO RADiotherapy Infrastructure for Europe; EORTC 1811 - NCT03818503) in 2019. This pragmatic, observational, prospective multi-cohort study uses a centralised database to collect real-world data on cancer patients, their radiotherapy treatments, and outcomes across Europe. It aims to generate evidence and new hypotheses to assess radiotherapy innovations. Results: After five years, two cohorts (OligoCare and ReCare) are actively recruiting patients. The platform has enabled the generation of new research hypotheses and the testing of innovative methodological strategies with the opening of the first international oncology Trial Within Cohorts (TWiCs). Engagement of the international radiotherapy community has been central to the development and sustainability of the infrastructure, while several barriers and limitations inherent to this type of real-world research have also been identified. Conclusion: The five-year experience of E2-RADIatE demonstrates the feasibility and added value of a large-scale, prospective, real-world, multi-cohort infrastructure to support evidence generation in radiotherapy, while highlighting regulatory and methodological challenges that must be addressed to maximise impact.
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