Clinical Trial Details

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)
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)
Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital (Cheltenham, United Kingdom)
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