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 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	APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) 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) 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 (Britisch Columbia Cancer Agency) (Vancouver, Canada) CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France) CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, 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 CEDEX, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame (Montreal, Canada) Erasmus MC (Rotterdam, Netherlands) Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital (Cheltenham, United Kingdom) Gustave Roussy (VILLEJUIF CEDEX, 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) 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 (Saint Herblain CEDEX, 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 (Cairo, Egypt) National University Hospital (Singapore, Singapore) Norrlands- Universitetssjukhus (Umea, Sweden) Nova Scotia Cancer Centre (Halifax, Nova Scotia, Canada) Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto (Ontario), Canada) Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Peter Maccallum Cancer Institute (Melbourne, 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) UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany) Universitaetsklinikum Wien - AKH unikliniken (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 (TUD) (Dresden, Germany)
Protocol summary	http://clinicaltrials.gov/study/NCT00182819
NCT number	NCT00182819
EudraCT	2004-002714-11
Financial Support	Educational Grant