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
Jessica Berger (Clinical Research Associate/Monitor) jessica.berger (at), EORTC Headquarters, Brussels
Luminita Copaceanu (Lead CRA) luminita.copaceanu (at), EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at), EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) beatrice.fournier (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
Jelle Stans (Junior RAM) jelle.stans (at), EORTC Headquarters, Brussels
Carla Sureda (Junior Clinical Operations Manager) carla.sureda (at), EORTC Headquarters, Brussels
Claudia Tomas (Project Manager) claudia.tomas (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) christine.debalincourt (at), EORTC Headquarters, Brussels
Type of cancer Testicular
Participating groups EORTC Genito-Urinary Cancers Group
Cancer Trials Ireland / ICORG
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)
Gustave Roussy (Villejuif, France)
Hopitaux Universitaires de Strasbourg - Hôpital civil (Strasbourg, France)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital General Universitario Dr Morales Meseguer (Murcia, Spain)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
IRCCS - Istituto Nazionale dei Tumori (Milano, Italy)
IRCCS - Istituto Nazionale dei Tumori (Milano, Italy)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
Inselspital (Bern, Switzerland)
Inselspital (Bern, Switzerland)
Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut Paoli-Calmettes (Marseille, France)
Institut de Cancerologie de Lorraine (Vandoeuvre-Les-Nancy, France)
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 -Standort Ev. Stift St. Martin (Koblenz, Germany)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
UKE - University Cancer Center (Hamburg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinik Dusseldorf (Duesseldorf, Germany)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Universitaetsklinikum Giessen und Marburg - Campus Marburg (Marburg, 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 Arnold Palmer Hospital Haley Center for Children’s Cancer and Blood Disorders (Orlando, United States of America)
Azienda Ospedaliera Busto Arsizio - Ospedale Saronno (Saronno, Italy)
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 12 De Octubre (Madrid, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, 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)
Roswell Park Cancer Institute (Buffalo, United States of America)
Royal Prince Alfred Hospital (Sydney, Australia)
Saint Francis Cancer Center (Tulsa, United States of America)
Saint Jude Children's Research Hospital (Memphis, United States of America)
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)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
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)
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