Study

EORTC-2334-BTG

177Lu-DOTATATE for recurrent MENingioma: a randomized phase II study

Trial Status

Recruiting

Dates

Date of activation: 10-Mar-2025

Data management at EORTC

Yes

Design

Phase 2
Randomized open label

Targeted Sample size

EORTC Groups: 136 - All Groups: 136

Treatment

Drug
Bevacizumab, Sunitinib, Everolimus, Hydroxycarbamide, Lutetium (177Lu) oxodotreotide, Octreotide

Study Staff

  • Nathalie Lisa Albert (Study Coordinator), Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern, Muenchen
  • 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
  • Julie Kitcheman (Study Coordinator), EORTC Liaison Office UK , Leeds
  • Susanne Ziegler (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Matthias Preusser (Study Co-Coordinator), Medical University of Vienna, University Hospital AKH Vienna, Vienna
  • Emeline Tabouret (Study Co-Coordinator), Hopital de La Timone (APHM), MARSEILLE
  • Christian Alfano (Project Manager), EORTC Headquarters, Brussels
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Ioannis Ntafoulis (Clinical Scientist), EORTC Headquarters, Brussels
  • Jose Silva (Medical representative), EORTC Headquarters, Brussels
  • Olga Basova (Statistician), EORTC Headquarters, Brussels
  • Thierry Gorlia (Statistician), EORTC Headquarters, Brussels
  • Nitish Jha (Statistical Analyst), EORTC Headquarters, Brussels
  • Fanny Grillet (TR Scientist), EORTC Headquarters, Brussels
  • Carla Sureda (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Sofiane Bendiab (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Shani De Coster (Data Manager), EORTC Headquarters, Brussels
  • Tim Verbiest (Data Manager), EORTC Headquarters, Brussels
  • Arnaud Poncin (Study Designer), EORTC Headquarters, Brussels
  • Leen Wijnen (Imaging DM), EORTC Headquarters, Brussels
  • Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jelle Stans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Daniel Urosa (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
  • Alexandra Latteux (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Abigirl Machingura (QoL Specialist), EORTC Headquarters, Brussels
  • Myrto Moutafi (Medical Advisor), EORTC Headquarters, Brussels

Type of cancer

  • Brain

Participating groups

  • EORTC Brain Tumor Group

Recruiting centers

  • A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria)
  • CHRU de Nancy - Hopitaux De Brabois (VANDOEUVRE LES NANCY CEDEX, France)
  • CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France)
  • CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE, France)
  • Centre Eugene Marquis (RENNES CEDEX, France)
  • Centre Leon Berard (Lyon, France)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • Hopital de La Timone (APHM) (MARSEILLE, France)
  • Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
  • Hospital Universitario 12 De Octubre (Madrid, Spain)
  • IRCCS-Regina Elena National Cancer Center (Roma, Italy)
  • Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
  • Medical University of Vienna, University Hospital AKH Vienna (Vienna, Austria)
  • Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
  • St. Olavs Hospital, Trondheim University Hospital (Trondheim, Norway)
  • UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
  • Universitaetsklinikum - Essen (Essen, Germany)
  • University Hospital Frankfurt- Klinik für Neurologie Funktionsbereich Neuroonkologie (Frankfurt Am Main, Germany)

Centers to be activated

  • APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France)
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy)
  • Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
  • Erasmus MC (Rotterdam, Netherlands)
  • Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
  • Hospital Universitario San Carlos (Madrid, Spain)
  • IRCCS - Istituto Oncologico Veneto (Padova, Italy)
  • IRCCS--Ospedale Bellaria-Bologna (Bologna, Italy)
  • Istituto Clinico Humanitas (Rozzano, Milano, Italy)
  • Odense University Hospital (Odense C, Denmark)
  • Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
  • Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
  • Rigshospitalet (Copenhagen, Denmark)
  • UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
  • UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
  • UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland)
  • University Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt am Main, Germany)
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)

Protocol summary

NCT number

NCT06326190