E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe

Overview

The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.

Primary outcome measures

• Number of patients treated with radiotherapy enrolled in the program [Time frame: 5 years]

Secondary outcome measures (5)

• Disease free survival [Time frame: 5 years]
• Loco-regional control [Time frame: 5 years]
• Distant metastasis free survival [Time frame: 5 years]
• Overall survival [Time frame: 5 years]
• Incidence of adverse events related to radiotherapy [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

• Pathologically confirmed cancer.
• Written informed consent for E²-RADIatE according to applicable legal and ethical requirements
• Planned use of radiotherapy
• Eligibility of the patient confirmed for at least one cohort confirmed
• Patients of 12 years and older

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Italy · 16 centers

• Ente Ecclesiastico Ospedale Generale Regionale "F. Miulli" — Acquaviva delle Fonti
• USL Toscana South East, Ospedale S. Donato — Arezzo
• Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia — Brescia
• Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi — Florence
• Istituto Clinico Humanitas — Milan
• IRCCS Ospedale San Raffaele — Milan
• Istituto Europeo di Oncologia — Milan
• Sacro Cuore Hospital — Negrar
• … and 8 more centers

Spain · 15 centers

• ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) — Badalona
• Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia — Barcelona
• Hospital De La Santa Creu I Sant Pau — Barcelona
• Hospital General Universitario Santa Lucia — Cartagena
• Hospital Universitario Reina Sofia — Córdoba
• Hospital Universitario Ramon y Cajal — Madrid
• Hospital Universitario La Paz — Madrid
• Hospitales HM Sanchinarro-CIOCC — Madrid
• … and 7 more centers

Belgium · 11 centers

• Onze Lieve Vrouw Ziekenhuis — Aalst
• Cliniques Universitaires Saint-Luc — Brussels
• Institut Jules Bordet — Brussels
• Universitair Ziekenhuis Gent — Ghent
• AZ Sint-Lucas & Volkskliniek — Ghent
• AZ Groeninge Kortrijk - Campus Kennedylaan — Kortrijk
• U.Z. Leuven - Campus Gasthuisberg — Leuven
• C.H.U. Sart-Tilman — Liège
• … and 3 more centers

United Kingdom · 7 centers

• NHS Grampian - Aberdeen Royal Infirmary — Aberdeen
• Velindre NHS Trust - Velindre Cancer Centre — Cardiff
• NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General — Glasgow
• The Christie NHS Foundation trust - The Christie NHS Foundation Trust — Manchester
• The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Wirra — Metropolitan Borough of Wirral
• Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital — Sheffield
• Somerset NHS Foundation Trust-Musgrove Park Hospital — Taunton

Switzerland · 6 centers

• Inselspital — Bern
• Kantonsspital Graubuenden — Chur
• Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie — Geneva
• Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds — La Chaux-de-Fonds
• Hopital du Valais - Hopital de Sion — Sion
• UniversitaetsSpital Zurich — Zurich

Germany · 5 centers

• Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH — Aachen
• Klinikum Bayreuth Gmbh — Bayreuth
• Universitaetsklinikum Carl Gustav Carus — Dresden
• Kliniken Maria Hilf GmbH — Mönchengladbach
• Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern — München

Netherlands · 4 centers

• Stichting Catharina Ziekenhuis — Eindhoven
• University Medical Center Groningen — Groningen
• Radboudumc - Radboud University Medical Center Nijmegen — Nijmegen
• Radiotherapiegroep Arnhem — Nijmegen

Austria · 3 centers

• Medical University of Graz - Radio-oncology — Graz
• Ordensklinikum Linz-Barmherzige Schwestern — Linz
• Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken — Vienna

Ireland · 3 centers

• St Luke Hospital & SLRON - SLRON - St. Luke'S Hospital Rathgar — Dublin
• Beacon Hospital — Dublin
• University Hospital Galway — Galway

Poland · 3 centers

• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodz — Lodz
• Kliniki Neuroradiochirurgii Sp. z o.o.-Radomskie Centrum Onkologii — Radom
• Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research I — Warsaw

Czechia · 1 center

• University Hospital Hradec Kralove — Hradec Králové

France · 1 center

• Clinique Pasteur-Lanroze (1174) — Brest

Israel · 1 center

• Sheba Medical Center Tel Hashomer — Ramat Gan

Slovenia · 1 center

• The Institute Of Oncology — Ljubljana

Publications

• Christ SM, Alongi F, Ricardi U, Scorsetti M, Livi L, Balermpas P, Lievens Y, Braam P, Jereczek-Fossa BA, Stellamans K, Ratosa I, Widder J, Peulen H, Dirix P, Bral S, Ramella S, Hemmatazad H, Khanfir K, Geets X, Jeene P, Zilli T, Fournier B, Ivaldi GB, Clementel E, Fortpied C, Oppong FB, Ost P, Guckenberger M. Cancer-specific dose and fractionation schedules in stereotactic body radiotherapy for ol PMID 38508239
• Nieder C, Willmann J, Andratschke NH. Prospective randomized clinical studies involving reirradiation: update of a systematic review. Strahlenther Onkol. 2023 Sep;199(9):787-797. doi: 10.1007/s00066-023-02118-1. Epub 2023 Jul 27. PMID 37500926

Identifiers

NCT: NCT03818503 · EORTC-1811

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗