EORTC-1945

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Stereotactic body radiotherapy in addition to standard of care treatment in patients with oligometastatic rare cancers (OligoRARE): a randomized, phase 3, open-label trial.

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 10-Jun-2021
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 200 - All Groups: 200
Treatment	Radiotherapy
Study Staff	Matthias Guckenberger (Study Coordinator) , UniversitaetsSpital Zurich, Zurich Piet Ost (Study Coordinator) , GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Daphne Debleu (Data Manager) , EORTC Headquarters, Brussels Ruxandra Dionisie (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Nathalie Elaut (Study Designer) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Irina Ghislain (QoL Specialist) , EORTC Headquarters, Brussels Leslie Herman (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Nitish Jha (Statistical Analyst) , EORTC Headquarters, Brussels Sylvie Ledroit (Clinical Operations Assistant) , EORTC Headquarters, Brussels Giulia Leonetti (Project Manager) , EORTC Headquarters, Brussels Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Felix Oppong (Statistician) , EORTC Headquarters, Brussels Valentina Pomella (Clinical Operations Manager) , EORTC Headquarters, Brussels Tania Rana (Junior RAM) , EORTC Headquarters, Brussels Corinne Sokeng (Statistical Analyst) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Maarten Spruyt (Study Designer) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer	Head and Neck Melanoma Soft Tissue and Bone Sarcoma Solid Tumors, Unspecified Thyroid Renal
Participating groups
Recruiting centers	Centre Oscar Lambret (LILLE CEDEX, France) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Gustave Roussy (VILLEJUIF CEDEX, France) Inselspital (Bern, Switzerland) Istituto Europeo di Oncologia (Milano, Italy) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitair Ziekenhuis Gent (Gent, Belgium)
Centers to be activated	Institut Jules Bordet (Anderlecht, Belgium) Kliniken Maria Hilf GmbH (Moenchengladbach, Germany) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Medical University Of Gdansk (Gdansk, Poland) Universita Di Torino - San Giovanni Battista (Torino, Italy) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
Protocol summary	http://clinicaltrials.gov/ct/show/NCT04498767
NCT number	NCT04498767
Financial Support	EORTC HQ Anticancer Fund Rising Tide Foundation for Clinical Cancer Research