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) , EORTC Headquarters, Brussels
Luminita Copaceanu (Lead CRA) , EORTC Headquarters, Brussels
Alessandro Fadel (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Carla Figueiredo (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Lucy Sepulveda (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels
Egle Venslovaite (Project Manager) , EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , 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)
APHP Sorbonne Univ - Hopital Tenon (PARIS, France)
Arnold Palmer Hospital Haley Center for Children’s Cancer and Blood Disorders (Orlando, United States of America)
Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom)
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, France)
Cancer Center of Kansas (Wichita, United States of America)
Centre Leon Berard (Lyon, France)
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany)
Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America)
Eastern Health - Box Hill Hospital (Box Hill, Australia)
Emory University/Winship Cancer Institute (Atlanta, United States of America)
Fondazione IRCCS - Policlinico San Matteo (Pavia, Italy)
Froedtert and the Medical College of Wisconsin (Milwaukee, United States of America)
Greenville Health System Cancer Institute-Eastside (Greenville, United States of America)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopitaux Universitaires de Strasbourg - Hôpital civil (STRASBOURG CEDEX, France)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital General Universitario Dr Morales Meseguer (Murcia, Spain)
Hospital Universitario 12 De Octubre (Madrid, 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 - Fondazione 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 Jules Bordet (Anderlecht, Belgium)
Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France)
Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France)
Klinikum Nuernberg- Standort Nord (Nuernberg, Germany)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (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 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)
Ohio State University Comprehensive Cancer Center (Columbus, United States of America)
Peter Maccallum Cancer Institute (Melbourne, Australia)
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Rhode Island Hospital / Brown University (Providence, United States of America)
Rigshospitalet (Copenhagen, Denmark)
Roswell Park Cancer Institute (Buffalo, United States of America)
Rotkreuzklinikum Muenchen (Muenchen, Germany)
Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom)
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)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
Siteman Cancer center- St. Louis (St Louis, United States of America)
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)
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)
Univ. of Chicago Duchossois Center Advanced Medicine (Chicago, United States of America)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, 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 Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
Universitaetsklinikum Ulm (Ulm, Germany)
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital (Southampton, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
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)
Vanderbilt Ingram Cancer Center - Breast Center (Nashville, United States of America)
Centers to be activated Azienda Ospedaliera Busto Arsizio - Ospedale Saronno (Saronno, Italy)
Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France)
Leeds General Infirmary (Leeds, United Kingdom)
NHS Grampian - Aberdeen Royal Infirmary (Aberdeen, United Kingdom)
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
Vivantes Klinikum Neukoelln (Berlin - Neukoelln, Germany)
Protocol summary
NCT number NCT02375204
EudraCT 2014-003930-17
Financial Support External Grant