Leveraging the potential of prospective registries for radiation oncology research: 5‑year experience from the EORTC‑ESTRO E²‑RADIatE project
Background and introduction
Conducting clinical research in radiotherapy remains challenging due to the incremental nature of technological advances, the need for long-term endpoints, and the complexity of large-scale trials. To address these limitations, EORTC and ESTRO launched E²-RADIatE in 2019, aiming to complement randomised controlled trials through prospective, real-world data collection across Europe.
Materials and methods
E²-RADIatE (EORTC 1811 – NCT03818503) is a pragmatic, observational, prospective multi-cohort study with a centralised database capturing data on cancer patients, radiotherapy treatments, and outcomes. The platform includes multiple cohorts, notably OligoCare and ReCare, and supports innovative methodologies such as Trials-within-Cohorts (TWiCs).
Results
After five years, E²-RADIatE has demonstrated the feasibility of a large-scale, pan-European real-world data infrastructure. The OligoCare and ReCare cohorts are actively recruiting, contributing to insights into radiotherapy practice across Europe. The platform has enabled the generation of new research hypotheses and the implementation of novel study designs, including the first international oncology TWiCs. Strong engagement from the radiotherapy community has supported its development, while regulatory, methodological, and operational challenges remain.
The E²-RADIatE experience highlights the added value of prospective registries in supporting evidence generation, methodological innovation, and clinical research in radiotherapy. While barriers persist, this approach represents a promising and scalable complement to traditional clinical trials.
Yolande Lievens, Damien C. Weber, Nicolaus Andratschke, Eralda Azizaj, Enrico Clementel, Claudio Fiorino, Matthias Guckenberger, Sarah Nuyens, Felix Oppong, Piet Ost, Daniel Portik, Umberto Ricardi, Joachim Widder, Jonas Willmann, Chiara Gasparotto, Denis Lacombe