EORTC-1308-BTG-ROG

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Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (The ROAM trial) / EORTC 1308

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 28-Apr-2016 Date Step1 close: 26-May-2021
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 60 - All Groups: 190
Treatment	Radiotherapy
Study Staff	Matthias Preusser (Study Coordinator) , Universitaetsklinikum Wien - AKH unikliniken, Vienna Damien Charles Weber (Study Coordinator) , Paul Scherrer Institute - Center for Proton Therapy (CPT), Villigen Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Miriam Presas (Junior RAM) , EORTC Headquarters, Brussels Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Egle Venslovaite (Project Manager) , EORTC Headquarters, Brussels Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer	Brain
Participating groups	EORTC Brain Tumor Group EORTC Radiation Oncology Group Trans-Tasman Radiation Oncology Group Inc Cancer Trials Ireland The Walton Centre NHS Foundation Trust
Recruiting centers	A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria) APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) AUSL Bologna - Ospedale Bellaria (Bologna, Italy) Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital (Romford Essex, United Kingdom) Beaumont Hospital (Dublin, Ireland) CHRU de Lille (LILLE CEDEX, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) Calvary Mater Newcastle (Waratah, Australia) Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Chris O'Brien Lifehouse (Camperdown NSW , Australia) Christchurch Hospital - Canterbury regional Cancer and Haematology service (Christchurch , New Zealand) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Complejo Hospitalario de Navarra (Pamplona, Spain) Derriford Hospital (Plymouth, United Kingdom) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Hospital Universitario 12 De Octubre (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia) (Girona, Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS - Istituto Neurologico Carlo Besta (Milano, Italy) Imperial College Healthcare NHS Trust - Charing Cross Hospital (London, United Kingdom) Institut Jules Bordet (Anderlecht, Belgium) King's College Hospital (London, United Kingdom) Liverpool Hospital (Liverpool, Australia) Mater Adult Hospital-Radiation Oncology Princess Alexandra Hospital Raymond Terrace  (South Brisbane, Australia) NHS - The Walton Centre (Liverpool, United Kingdom) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Peter Maccallum Cancer Institute (Melbourne, Australia) Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) Royal Victoria Hospital (Belfast, United Kingdom) Royal Brisbane And Women's Hospital (Herston - Brisbane, Australia) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Royal North Shore Hospital (St Leonards, Australia) Salford Royal Hospital (Salford, United Kingdom) Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (Sheffield, United Kingdom) Sir Charles Gairdner Hospital (Nedlands, Australia) UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitaetsklinikum Bonn (Bonn, Germany) Universitaetsspital Basel (Basel, Switzerland) University College London Medical School (London, United Kingdom) University Hospital Southampton NHS Foundation Trust - Southampton General Hospital (Southampton, United Kingdom) University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom) University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital (Stoke-On-Trent, United Kingdom) Velindre NHS Trust - Velindre Cancer Centre (Cardiff, United Kingdom) Waikato Hospital (Hamilton, New Zealand) Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia)
Protocol summary	http://clinicaltrials.gov/study/
NCT number
Financial Support	EORTC HQ EORTC Group