Study
EORTC-1901-LCG
PRophylactic cerebral Irradiation or active MAgnetic resonance imaging surveillance in small-cell Lung cancer patients (PRIMALung study)
Trial Status
Recruiting
Dates
Date of activation: 27-Oct-2022
Data management at EORTC
Yes
Design
Phase 3
Randomized open label
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
- Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
- Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
- Selin Gundogan (Clinical Operations Manager), EORTC Headquarters, Brussels
- Lore Hermans (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
- Davide Passariello (Project 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, Imaging DM), 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)
- 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)
- Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom)
- Medical University Of Gdansk (Gdansk, Poland)
- Medical University of Graz - Radio-oncology (Graz, Austria)
- NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
- 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)
- ZAS Augustinus (previous GZA) (Wilrijk, Belgium)
Centers to be activated
- APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France)
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma (Verona, Italy)
- CHU de Saint-Etienne - Hopital Nord (Saint Priest en Jarez, France)
- 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)
- Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
- University Medical Center Groningen (Groningen, Netherlands)
Protocol summary
NCT number
NCT04790253