Clinical Trial Details

EORTC-22033-26033-ROG-BTG

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Primary chemotherapy with temozolomide vs.radiotherapy in patients with low grade gliomas after stratification for genetic 1p loss : a phase III study

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 12-Jul-2005
Date Step1 close: 26-Mar-2010
Date Step2 close: 28-Mar-2013
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 450 - All Groups: 700
Treatment Radiotherapy, Drug
Temozolomide
Study Staff Brigitta Baumert (Study Coordinator) , Kantonsspital Graubuenden, Chur
Vassilis Golfinopoulos (Clinical Research Physician) , EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Marie-Ange Lentz (Data Manager) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Tina Verschuere (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
EORTC Radiation Oncology Group
NCIC Clinical Trial Group
Trans-Tasman Radiation Oncology Group Inc
University College of London
Recruiting centers AUSL Bologna - Ospedale Bellaria (Bologna, Italy)
Alfred Hospital (Prahran, Australia)
Allan Blair Cancer Centre (Regina, Saskatchewan, Canada)
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
Austin Health - Austin hospital (Heidelberg VIC, Australia)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy)
BC Cancer Agency (Vancouver, Canada)
CHU de Grenoble - La Tronche - Hopital A. Michallon (Grenoble, France)
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Calvary Mater Newcastle (Waratah, Australia)
Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Cancercare Manitoba (Winnipeg, Canada)
Canterbury District Health Board (Christchurch, New Zealand)
Centre Eugene Marquis (Rennes, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame (Montreal, Canada)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Erasmus MC (Rotterdam, Netherlands)
Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital (Cheltenham, United Kingdom)
Gustave Roussy (Villejuif, France)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Hamilton Health Sciences, Juravinski Cancer Centre (Hamilton, Canada)
Hopital Universitaires Erasme (Brussels, Belgium)
Hopital de La Timone (APHM) (Marseille, France)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia) (Girona, Spain)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
Institut Bergonie (Bordeaux, France)
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Nantes - St. Herblain, France)
Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
Instituut Verbeeten (Tilburg, Netherlands)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Linkoping University Hospital (Linkoping, Sweden)
Liverpool Hospital (Liverpool, Australia)
London Regional Cancer Center (London, Canada)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
Mater Adult Hospital-Radiation Oncology Princess Alexandra Hospital Raymond Terrace  (South Brisbane, Australia)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
National Cancer Institute (Cairo, Egypt)
National University Hospital (Singapore, Singapore)
Nova Scotia Cancer Centre (Halifax, Nova Scotia, Canada)
Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto, Canada)
Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
Ospedale San Raffaele (Milano, Italy)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
Peter Maccallum Cancer Institute (East Melbourne VIC, Australia)
Prince Of Wales Hospital (Randwick - Sydney, Australia)
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Rambam Health Care Campus, Oncology Institute (Haifa, Israel)
Royal Free Hospital (London, United Kingdom)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom)
Royal North Shore Hospital (St Leonards, Australia)
Royal Prince Alfred Hospital (Sydney, Australia)
Saint John Regional Hospital (Saint John, New Brunswick, Canada)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
Sir Charles Gairdner Hospital (Nedlands, Australia)
Skane University Hospital (Lund, Sweden)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The James Cook University Hospital (Middlesbrough, United Kingdom)
Tom Baker Cancer Centre (Calgary, Canada)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Umea - Norrlands- Universitetssjukhus (Umea, Sweden)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
University College Hospital (London, United Kingdom)
University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada)
University Medical Center Groningen (Groningen, Netherlands)
Uppsala University Hospital - Akademiska Sjukhuset (Uppsala, Sweden)
Centers to be activated Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00182819
NCT number NCT00182819
EudraCT 2004-002714-11
Financial Support Educational Grant