Study

EORTC-2227-BTG

Lomustine with and without reirradiation for first progression of glioblastoma: a randomized phase III study

Study documentation Back to result

Trial Status

Recruiting

Dates

Date of activation: 15-Mar-2024

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

All Groups: 490

Treatment

Radiotherapy, Drug
Lomustine

Study Staff

  • Justine Bobinnec (Study Coordinator), EORTC Liaison Office France, Paris
  • Kirsten Brade (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Ivan Jelas (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Matthias Preusser (Study Coordinator), Medical University of Vienna, University Hospital AKH Vienna, Vienna
  • Susanne Ziegler (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Giuseppe Minniti (Study Co-Coordinator), Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola, Roma
  • Tomas Kazda (Y-ECI Coordinator), Masaryk Memorial Cancer Institute, Brno
  • Christian Alfano (Project Manager), EORTC Headquarters, Brussels
  • Christopher Doty (Project Manager), EORTC Headquarters, Brussels
  • Jose Silva (Clinical Research Physician), EORTC Headquarters, Brussels
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Caroline Quoilin (Medical representative), EORTC Headquarters, Brussels
  • Thierry Gorlia (Statistician), EORTC Headquarters, Brussels
  • Jerome Rapion (Statistical Analyst), EORTC Headquarters, Brussels
  • Boubker Ait Brik (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Valentina Pomella (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Marie Delsaute (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Amaya Gonzalez (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Tim Verbiest (Data Manager), EORTC Headquarters, Brussels
  • Peter De Burghgraeve (Study Designer), EORTC Headquarters, Brussels
  • Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Ana Isabel Lanza (Junior PVM), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Daniel Urosa (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Salvatore Mazza (Lead CRA), EORTC Headquarters, Brussels
  • Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
  • Hanne Belien (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Raffaella De Pietro (Fellow), EORTC Headquarters, Brussels
  • Stephane Lejeune (International Affairs and Policies Manager), EORTC Headquarters, Brussels
  • Abigirl Machingura (QoL Specialist), EORTC Headquarters, Brussels
  • Lotte van der Weijst (QoL Specialist), EORTC Headquarters, Brussels
  • Anja Mestnik (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Katheline Vander Heggen (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Enrico Clementel (RTQA Manager), EORTC Headquarters, Brussels
  • Coreen Corning (RTQA Officer), EORTC Headquarters, Brussels
  • Volha Hertsyk (RTQA Officer), EORTC Headquarters, Brussels
  • Luiza Souza (RTQA Officer), EORTC Headquarters, Brussels

Type of cancer

  • Brain

Participating groups

  • EORTC Brain Tumor Group
  • Swiss Cancer Institute (formerly Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung)

Recruiting centers

  • A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria)
  • APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
  • APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France)
  • AZORG (previous Onze Lieve Vrouw ZK) (Aalst, Belgium)
  • Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy)
  • Azienda ospedaliero Univ Policlinico Umberto I (Roma, Italy)
  • CHU Amiens Picardie - Site Sud (Amiens, France)
  • CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France)
  • CHU de Lille (LILLE CEDEX, France)
  • CHU de Nice - Hopital Pasteur (NICE, France)
  • CLCC - Jean Perrin (CLERMONT FERRAND , France)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • ETZ - St. Elisabethziekenhuis (Tilburg, Netherlands)
  • Erasmus MC (Rotterdam, Netherlands)
  • Grand Hopital de Charleroi - Site Les Viviers (Gilly, Belgium)
  • Hospital Universitario 12 De Octubre (Madrid, Spain)
  • ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
  • ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
  • IRCCS - Istituto Oncologico Veneto (Padova, Italy)
  • IRCCS--Ospedale Bellaria-Bologna (Bologna, Italy)
  • Institut Public De Cancerologie Strauss Europe-Strauss Institute (Strasbourg, France)
  • Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France)
  • Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France)
  • Istituto Clinico Humanitas (Rozzano, Milano, Italy)
  • Kepler University Hospital - Neuromed campus (Linz, Austria)
  • Leiden University Medical Centre (Leiden, Netherlands)
  • Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
  • Masaryk Memorial Cancer Institute (Brno, Czech Republic)
  • Medical University of Vienna, University Hospital AKH Vienna (Vienna, Austria)
  • Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
  • Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
  • Region Midtjylland - Aarhus University Hospital-Skejby (Aarhus, Denmark)
  • St. Olavs Hospital, Trondheim University Hospital (Trondheim, Norway)
  • U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
  • Univ. Knappschaft Krankenhaus Bochum (Bochum-Langendreer, Germany)
  • UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
  • UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland)
  • Universitaetsklinikum - Essen (Essen, Germany)
  • Universitaetsklinikum Erlangen-Schwabachanlage (Erlangen, Germany)
  • Universitaetsklinikum Jena (Jena, Germany)
  • Universitaetsklinikum Koeln (Koeln, Germany)
  • Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
  • Universitaetsklinikum Regensburg (Regensburg, Germany)
  • Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
  • Universitair Ziekenhuis Gent (Gent, Belgium)
  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Centers to be activated

  • Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A. (Athens, Greece)
  • Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola (Roma, Italy)
  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)

Protocol summary

http://clinicaltrials.gov/study/NCT05904119

NCT number

NCT05904119