EORTC-1901-LCG

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PRophylactic cerebral Irradiation or active MAgnetic resonance imaging surveillance in small-cell Lung cancer patients (PRIMALung study)

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 27-Oct-2022
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 450 - All Groups: 600
Treatment	Radiotherapy
Study Staff	Corinne Faivre-Finn (Study Coordinator) , The Christie NHS Foundation Trust, Manchester Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Corinne Daumer (Project Manager) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Selin Gundogan (Clinical Operations Manager) , EORTC Headquarters, Brussels Piet Gutscoven (Study Designer) , EORTC Headquarters, Brussels Leslie Herman (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Gracia Katanga (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Antonin Levy (Y-ECI Coordinator) , Gustave Roussy, VILLEJUIF CEDEX Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Lore Meelberghs (Study Designer) , EORTC Headquarters, Brussels Miriam Presas (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Nathalie Ropson (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Cathy Van de Wiele (Data Manager) , EORTC Headquarters, Brussels Cathy Van de Wiele (Imaging DM) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Leen Wijnen (Data Manager) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer	Lung
Participating groups	EORTC Lung Cancer Group UNICANCER
Recruiting centers	AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) C.H.U. Sart-Tilman (Liege, Belgium) CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France) Centre Catalan d'Oncologie (Perpignan, France) Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Henri Becquerel (ROUEN CEDEX, France) Centre Hopitalier Intercommunal De Creteil (Creteil, France) Centre Hospitalier Bretagne Sud - Site du Scorff (LORIENT CEDEX, France) Centre Hospitalier Departemental Vendee (LA ROCHE SUR YON CEDEX 9, France) Centre Hospitalier Metropole Savoie (Chambery, France) Centre Hospitaliler Cholet (CHOLET CEDEX, France) Centre Oscar Lambret (LILLE CEDEX, France) Centre d'Oncologie Saint-Yves (Vannes, France) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital (Cheltenham, United Kingdom) Gustave Roussy (VILLEJUIF CEDEX, France) Hospital Universitario Puerta De Hierro (Majadahonda, Spain) Inselspital (Bern, Switzerland) Institut Bergonie (Bordeaux, France) Institut Jules Bordet (Anderlecht, Belgium) Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France) Institut Sainte Catherine (AVIGNON CEDEX 9, France) Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France) Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France) Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) Kantonsspital St Gallen (St Gallen, Switzerland) Medical University Of Gdansk (Gdansk, Poland) Medical University of Graz - Radio-oncology (Graz, Austria) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Polyclinique de l'Ormeau (Tarbes, France) RHNe - La Chaux de Fonds (La Chaux-de-Fonds, Switzerland) Regional Cancer Centre (Olsztyn, Poland) Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) The Christie NHS Foundation Trust (Manchester, United Kingdom) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
Centers to be activated	ASST-Bergamo Ospedale Treviglio-Caravaggio (Treviglio, Italy) Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma (Verona, Italy) Centre Antoine Lacassagne (NICE CEDEX 2, France) Complejo Hospitalario Universitario Insular Materno Infantil (Las Palmas de Gran Canaria, Spain) Fondazione IRCCS - Policlinico San Matteo (Pavia, Italy) Hospi Grand Ouest - Clinique Mutualiste de l’Estuaire (Saint Nazaire, France) Hospital Universitario Infanta Cristina (Badajoz, Spain) IRCCS Ospedale San Martino (Genova, Italy) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany) University Medical Center Groningen (Groningen, Netherlands)
Protocol summary	http://clinicaltrials.gov/study/NCT04790253
NCT number	NCT04790253
Financial Support	Astra Zeneca EORTC LCG KCE / Ligue Contre le Cancer / Swiss Cancer League / Unicancer