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

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