Clinical Trial Details


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A Randomized phase III trial comparing conventional-dose chemotherapy using paclitaxel, ifosfamide, and cisplatin (TIP) with high dose chemotherapy using mobilizing paclitaxel plus ifosfamide followed by High-dose carboplatin and etoposide (TI-CE) as first salvage treatment in relapsed or refractory germ cell tumors

Study documentation

Trial Status Recruiting
Dates Date of activation: 11-Jan-2016
Data management at EORTC No
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 192 - All Groups: 420
Treatment Drug
Carboplatin, Cisplatin, Etoposide, Filgrastim, Ifosfamide, Paclitaxel, Pegfilgrastim
Study Staff Thomas Powles (Study Coordinator) , Barts Health NHS Trust - St. Bartholomew'S Hospital, London
Kimberley Ceulemans (Clinical Research Associate/Monitor) kimberley.ceulemans (at), EORTC Headquarters, Brussels
Cherelle Clarke (Regulatory Affairs Administrator) cherelle.clarke (at), EORTC Headquarters, Brussels
Laurence Collette (Statistician) laurence.collette (at), EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at), EORTC Headquarters, Brussels
Marianna Del Sole (Clinical Research Associate/Monitor) marianna.delsole (at), EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) beatrice.fournier (at), EORTC Headquarters, Brussels
Joana Mendes (Regulatory Affairs Administrator) joana.mendes (at), EORTC Headquarters, Brussels
Bart Meulemans (Data Manager) bart.meulemans (at), EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at), EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at), EORTC Headquarters, Brussels
Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Type of cancer Testicular
Participating groups EORTC Genito-Urinary Cancers Group
Cancer Trials Ireland
Institute of Cancer Research - Clinical Trials & Statistics Unit
The Australian and New Zealand Urogenital and Prostate
Recruiting centers AO Ospedale di Circolo di Busto Arsizio (Busto Arsizio, Italy)
Assistance Publique - Hopitaux de Paris - Hopital Tenon (Paris, France)
Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom)
Centre Leon Berard (Lyon, France)
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Fondazione IRCCS Istituto Nazionale dei Tumori (Milano, Italy)
Gustave Roussy (Villejuif, France)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital General Universitario Dr Morales Messeguer (Murcia, Spain)
Hôpitaux Universitaires de Strasbourg - Hôpital civil (Strasbourg, France)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (Hospitalet de Llobregat, Spain)
Inselspital (Bern, Switzerland)
Inselspital (Bern, Switzerland)
Institut Claudius Regaud (Toulouse, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut Paoli-Calmettes (Marseille, France)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy)
Klinikum Der Philipps-Universitaet Marburg (Marburg, Germany)
Klinikum Nuernberg- Standort Nord (Nuernberg, Germany)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Policlinico San Matteo (Pavia, Italy)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Rigshospitalet (Copenhagen, Denmark)
Rotkreuzklinikum Muenchen (Muenchen, Germany)
Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
St. James'S Hospital (Dublin, Ireland)
Stiftungsklinikum Mittelrhein (Koblenz, Germany)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
Universitaets-Krankenhaus Eppendorf (Hamburg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinik Dusseldorf (Duesseldorf, Germany)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Universitaetsklinikum Ulm (Ulm, Germany)
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital (Southampton, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Centers to be activated Box Hill Hospital (Box Hill, Australia)
Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Cancer Center of Kansas (Wichita, United States of America)
Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America)
Emory University/Winship Cancer Institute (Atlanta, United States of America)
Froedtert and the Medical College of Wisconsin (Milwaukee, United States of America)
Greenville Health System Cancer Institute-Eastside (Greenville, United States of America)
Hospital Universitario Central De Asturias (Oviedo, Spain)
Institut de Cancerologie de Lorraine (Vandoeuvre-Les-Nancy, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
Leeds General Infirmary (Leeds, United Kingdom)
Loma Linda University (Loma Linda, United States of America)
Mayo Clinic (Rochester, United States of America)
Memorial Sloan-Kettering Cancer Center - Memorial hospital (New York, United States of America)
NHS Grampian - Aberdeen Royal Infirmary (Aberdeen, United Kingdom)
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
Ohio State University Comprehensive Cancer Center (Columbus, United States of America)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
Peter Maccallum Cancer Institute (East Melbourne, Australia)
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
Rhode Island Hospital / Brown University (Providence, United States of America)
Royal Prince Alfred Hospital (Sydney, Australia)
Saint Jude Children's Research Hospital (Memphis, United States of America)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Institute Of Oncology (Ljubljana, Slovenia)
The University of Texas MD Anderson Cancer Center (Houston, United States of America)
UCSF Helen Diller Family Comprehensive Cancer Center (San Francisco, United States of America)
USC Norris Comprehensive Cancer Center (Los Angeles, United States of America)
USC Norris Comprehensive Cancer Center (Los Angeles, United States of America)
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
University Of Chicago Comprehensive Cancer Center (Chicago, United States of America)
University Of Pittsburgh Cancer Institute (Pittsburgh, United States of America)
University of Oklahoma - Health Science Center (Oklahoma City, United States of America)
University of Pennsylvania - Abramson Cancer Center (Philadelphia, United States of America)
Virgen del Rocio University Hospital (Sevilla, Spain)
Vivantes Klinikum Neukoelln (Berlin, Germany)
Washington University School of Medicine - St. Louis (Saint Louis, United States of America)
Protocol summary
NCT number NCT02375204
EudraCT 2014-003930-17