| Trial Status | Recruiting |
| Dates | Date of activation: 03-Dec-07 |
| Data management at EORTC | Full |
| Phase | 3 |
| Randomized trial | Yes |
| Type | Adjuvant |
| Targeted Sample size | EORTC Groups: 450 - All Groups: 748 |
| Number of steps | 3 |
| Drug | Temozolomide |
| Study Staff | Brigitta Baumert (Study Coordinator) - MediClin Robert Janker Clinic, Bonn Martin J. van den Bent (Study Coordinator) - Erasmus MC - Daniel den Hoed Cancer Center, Rotterdam Thierry Gorlia (Statistician) - EORTC Headquarters, Brussels Lies Meirlaen (Data Manager) - EORTC Headquarters, Brussels Vassilis Golfinopoulos (Coordinating Physician) - EORTC Headquarters, Brussels Jonathan Steuve (Project Manager) - EORTC Headquarters, Brussels, jonathan.steuve( at )eortc.be, +32 27741039 |
| Type of cancer | |
| Participating Groups | EORTC Brain Tumor Group(Coordinating Group) EORTC Radiation Oncology Group Cancer Trials Support Unit Cooperative Trials Group for Neuro-Oncology Medical Research Council Clinical Trial Unit NCIC Clinical Trial Group Radiation Therapy Oncology Group |
| Centers authorized by EORTC | Royal North Shore Hospital (St Leonards, Australia) - Inst. 950 Royal Prince Alfred Hospital (Sydney, Australia) - Inst. 951 Royal Melbourne Hospital (Parkville, Australia) - Inst. 1059 Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) - Inst. 1060 Alfred Hospital (Prahran, Australia) - Inst. 1062 Sir Charles Gairdner Hospital (Nedlands, Australia) - Inst. 1064 Austin-Repatriation Medical Centre (Heidelberg, Australia) - Inst. 1075 Flinders Medical Centre (Bedford Park, Australia) - Inst. 1079 Royal Hobart Hospital (Hobart, Australia) - Inst. 1083 St Vincent'S Hospital (Fitzroy (melbourne), Australia) - Inst. 1084 ZNA Middelheim (Antwerpen, Belgium) - Inst. 114 Cliniques Universitaires St. Luc (Brussels, Belgium) - Inst. 121 Universitair Ziekenhuis Brussel (Brussels, Belgium) - Inst. 128 U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147 Clinique Notre-Dame (Charleroi, Belgium) - Inst. 1218 Algemeen Ziekenhuis Sint Lucas (Gent, Belgium) - Inst. 1248 CHUM - Hopital Notre-Dame (Montreal, Canada) - Inst. 752 University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada) - Inst. 754 London Regional Cancer Center (London, Canada) - Inst. 756 Cross Cancer Institute (Edmonton - Alberta, Canada) - Inst. 871 Cancercare Manitoba (Winnipeg, Canada) - Inst. 886 Tom Baker Cancer Centre (Calgary, Canada) - Inst. 1754 Allan Blair Cancer Centre (Regina, Saskatchewan, Canada) - Inst. 1808 Centre Antoine Lacassagne (Nice, France) - Inst. 218 Institut Gustave Roussy (Villejuif, France) - Inst. 225 Assistance Publique - Hôpitaux de Paris - La Pitié Salpétrière AP-HP (Paris, France) - Inst. 233 Centre Eugene Marquis (Rennes, France) - Inst. 272 Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone (Marseille, France) - Inst. 287 CHU de Nancy - Hopital St Julien (Nancy, France) - Inst. 2300 Universitaetsklinikum Bonn (Bonn, Germany) - Inst. 416 Universitaetsklinikum Koeln (Koeln, Germany) - Inst. 508 Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany) - Inst. 514 Medizinische Hochschule Hannover (Hannover, Germany) - Inst. 528 Universitaetskliniken Regensburg (Regensburg, Germany) - Inst. 933 Eberhard Karls Universitaet - Universitaetsklinikum Tuebingen (Tuebingen, Germany) - Inst. 3063 Ospedale San Raffaele (Milano, Italy) - Inst. 773 Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino (Torino, Italy) - Inst. 3887 Ospedale Bellaria (Bologna, Italy) - Inst. 3906 Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (barcelona), Spain) - Inst. 381 Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland) - Inst. 451 UniversitaetsSpital Zurich - Division of Oncology (Zurich, Switzerland) - Inst. 453 Erasmus MC - Daniel den Hoed Cancer Center (Rotterdam, The Netherlands) - Inst. 302 Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands) - Inst. 304 Vrije Universiteit Medisch Centrum (Amsterdam, The Netherlands) - Inst. 308 Medisch Centrum Haaglanden - Westeinde (Den Haag, The Netherlands) - Inst. 311 University Medical Center Groningen (Groningen, The Netherlands) - Inst. 335 Academisch Medisch Centrum - Universiteit van Amsterdam (Amsterdam, The Netherlands) - Inst. 342 Maastro Clinic - Maastricht Radiation Oncology (Maastricht, The Netherlands) - Inst. 4900 St John's Mercy Medical Center (St Louis, U.S.A.) - Inst. 9233 Reading Hospital and Medical Center (West Reading, U.S.A.) - Inst. 9234 Wesley Medical Center (Wichita, U.S.A.) - Inst. 9238 University of Florida (Gainesville, U.S.A.) - Inst. 9258 Cancer Treatment Center (Wooster, U.S.A.) - Inst. 9259 Summa Health System - Summa Barberton Hospital (Barberton, U.S.A.) - Inst. 9266 Norton Health Care Pavilion - Downtown (Louisville, U.S.A.) - Inst. 9463 McKay-Dee Hospital Center (Ogden, U.S.A.) - Inst. 9532 Adventist La Grange Memorial Hospital (La Grange, U.S.A.) - Inst. 9534 University Medical Center Brackenridge (Austin, U.S.A.) - Inst. 9535 Columbia University Medical Center (New York, U.S.A.) - Inst. 9536 Tacoma General Hospital - Northwest CCOP (Tacoma, U.S.A.) - Inst. 9544 Nebraska Medical Center (Omaha, U.S.A.) - Inst. 9430 OSF Saint Francis Medical Center - Radiation Oncology Service at the Central Illinois Comprehensive CC (Peoria, U.S.A.) - Inst. 9458 Community Cancer Center Foundation (Normal, U.S.A.) - Inst. 9459 Illinois CancerCare-Peoria (Peoria, U.S.A.) - Inst. 9460 OSF Saint Francis Medical Center (Peoria, U.S.A.) - Inst. 9461 Norton Suburban Hospital (Louisville, U.S.A.) - Inst. 9462 Froedtert and the Medical College of Wisconsin (Milwaukee, U.S.A.) - Inst. 9241 Arizona Oncology Services Foundation (Phoenix, U.S.A.) - Inst. 9246 Saint Vincent Oncology Center (Indianapolis, U.S.A.) - Inst. 9250 Rapid City Regional Hospital (Rapid City, U.S.A.) - Inst. 9255 Henry Ford Hospital (Detroit, U.S.A.) - Inst. 9261 Virginia Mason CCOP (Seattle, U.S.A.) - Inst. 9414 Saint Luke's University Hospital, Bethlehem Campus (Bethlehem, U.S.A.) - Inst. 9094 Saint Vincent Hospital (Green Bay, U.S.A.) - Inst. 9326 Case Western Reserve University School of Medicine (Cleveland, U.S.A.) - Inst. 9188 Cedars-Sinai Medical Center (Los Angeles, U.S.A.) - Inst. 9191 Massachussets General Hospital Cancer Center (Boston, U.S.A.) - Inst. 9219 Via Christi Regional Medical Center (Wichita, U.S.A.) - Inst. 9239 Penn State M.S. Hershey Medical Center (Hershey, U.S.A.) - Inst. 8692 Virginia Commonwealth University (Richmond, U.S.A.) - Inst. 9352 Parkview Hospital (Fort Wayne, U.S.A.) - Inst. 9353 Oncology Associates PC (Fort Wayne, U.S.A.) - Inst. 9354 UPMC - Heritage Valley Health System - The Medical Center (Beaver, U.S.A.) - Inst. 9360 Carolinas Medical Center (Charlotte, U.S.A.) - Inst. 9361 University Of Utah - Huntsman Cancer Institute (Salt Lake City, U.S.A.) - Inst. 6884 Lehigh Valley Hospital (Allentown, U.S.A.) - Inst. 6889 June E. Nylen Cancer Center (Sioux City, U.S.A.) - Inst. 8643 Spartanburg Regional Medical Center (Spartanburg, U.S.A.) - Inst. 8657 Thomas Jefferson University Hospital (Philadelphia, U.S.A.) - Inst. 8666 Swedish Cancer Institute (Seattle, U.S.A.) - Inst. 8691 Md Anderson Cancer Center (Houston, U.S.A.) - Inst. 6809 Akron City Hospital - Summa Health System (Akron, U.S.A.) - Inst. 6831 Emory University (Atlanta, U.S.A.) - Inst. 6840 University of Wisconsin Hospital and Clinics - Comprehensive Cancer Center (Madison, U.S.A.) - Inst. 6841 University Of Chicago Medicine (Chicago, U.S.A.) - Inst. 6853 Cleveland Clinic Foundation (Cleveland, U.S.A.) - Inst. 6873 University of Kentuky (Lexington, U.S.A.) - Inst. 9435 Washington University School of Medicine - St. Louis (Saint Louis, U.S.A.) - Inst. 9449 UHHS - Westlake Medical Center (Westlake, U.S.A.) - Inst. 9393 Brigham and Women's Hospital (Boston, U.S.A.) - Inst. 9395 McFarland Clinic (Ames, U.S.A.) - Inst. 9244 University of Texas Medical Branch (Galveston, U.S.A.) - Inst. 9366 West Michigan Cancer Center (Kalamazoo, U.S.A.) - Inst. 9317 Mayo Clinic in Florida (Jacksonville, U.S.A.) - Inst. 9368 State University of New York Upstate Medical University (New York, U.S.A.) - Inst. 9404 Maine Medical Center (Scarborough, U.S.A.) - Inst. 9405 Saint Joseph Mercy Hospital (Ann Arbor, U.S.A.) - Inst. 9423 Providence Regional Cancer Partnership (Everett, U.S.A.) - Inst. 9434 UCSF University of California San Francisco Medical Center-Mount Zion (San Francisco, U.S.A.) - Inst. 9383 Dartmouth Hitchcock Medical Center (Lebanon, U.S.A.) - Inst. 9420 Waukesha Memorial Hospital (Waukesha, U.S.A.) - Inst. 9421 Methodist Estabrook Cancer Center (Omaha, U.S.A.) - Inst. 9422 Utah Valley Regional Medical Center (Provo, U.S.A.) - Inst. 9300 MetroHealth Medical Center (Cleveland, U.S.A.) - Inst. 9301 Medical University of South Carolina (Charleston, U.S.A.) - Inst. 9315 Southwest General Health Center Ireland Cancer Center (Middleburg Heights, U.S.A.) - Inst. 9386 Ohio State University Medical Center (Columbus, U.S.A.) - Inst. 9311 LDS Hospital (Salt Lake City, U.S.A.) - Inst. 9312 Intermountain Medical Center (Murray, U.S.A.) - Inst. 9313 Dixie Medical Center Regional Cancer Center (Saint George, U.S.A.) - Inst. 9314 Gundersen Lutheran (La Crosse, U.S.A.) - Inst. 9327 UHHS-Chagrin Highlands Medical Center (Orange Village, U.S.A.) - Inst. 9375 Western Reserve University (Cleveland, U.S.A.) - Inst. 9376 Boston Medical Center (Boston, U.S.A.) - Inst. 9403 Methodist Hospital (Houston, U.S.A.) - Inst. 9406 Loyola University Medical Center (Maywood, U.S.A.) - Inst. 9407 Saint Mary's Hospital (Green Bay, U.S.A.) - Inst. 9329 Cancer Centers of the Carolinas - Faris Road (Greenville, U.S.A.) - Inst. 9330 Cancer Centers of the Carolinas - Greer Radiation Oncology (Greer, U.S.A.) - Inst. 9331 Cancer Centers of the Carolinas - Seneca (Seneca, U.S.A.) - Inst. 9332 Northwestern University (Chicago, U.S.A.) - Inst. 9343 Abington Memorial Hospital (Abington, U.S.A.) - Inst. 9263 University of Rochester - James P. Wilmot Cancer Center (Rochester, U.S.A.) - Inst. 9268 Highland Hospital (Rochester, U.S.A.) - Inst. 9269 Memorial Health University Medical Center (Savannah, U.S.A.) - Inst. 9285 Cancer Care Center, Incorporated (Salem, U.S.A.) - Inst. 9260 Cancer Centers of the Carolinas - Eastside (Greenville, U.S.A.) - Inst. 9307 Florida Hospital (Orlando, U.S.A.) - Inst. 9322 Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital (Leeds, United Kingdom) - Inst. 601 Imperial College Healthcare NHS Trust - Charing Cross Hospital (London, United Kingdom) - Inst. 603 Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom) - Inst. 605 Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) - Inst. 609 Christie NHS Foundation Trust (Manchester, United Kingdom) - Inst. 610 Royal Marsden Hospital - Sutton, Surrey (Sutton, United Kingdom) - Inst. 616 University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom) - Inst. 664 Cheltenham General Hospital (Cheltenham, United Kingdom) - Inst. 666 Royal Devon And Exeter Hospital (Exeter - Devon, United Kingdom) - Inst. 682 Derriford Hospital (Plymouth, United Kingdom) - Inst. 6997 Nottingham University Hospitals NHS Trust - City Hospital campus (Nottingham, United Kingdom) - Inst. 6998 Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital (Preston, United Kingdom) - Inst. 7065 Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) - Inst. 619 University College Hospital (London, United Kingdom) - Inst. 622 Guy's and St Thomas' NHS - Guy's Hospital (London, United Kingdom) - Inst. 625 Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom) - Inst. 632 NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) - Inst. 641 Clatterbridge Cancer Centre NHS Foundation Trust (Bebington, Wirral, United Kingdom) - Inst. 659 |
| Protocol summary | Cancer.gov (PDQ) ClinicalTrials.gov |
| NCT number | NCT00626990 |
| EudraCT | 2006-001533-17 |
| Protocol documents in PDF (requires password) | Study documentation |