Study
EORTC-1407-GUCG
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
Trial Status
Closed to Patient Entry
Dates
Date of activation: 11-Jan-2016
Date Step1 close: 24-Oct-2022
Date Step1 close: 24-Oct-2022
Data management at EORTC
No
Design
Phase 3
Randomized open label
Randomized open label
Targeted Sample size
EORTC Groups: 192 - All Groups: 420
Treatment
Drug
Carboplatin, Cisplatin, Etoposide, Filgrastim, Ifosfamide, Paclitaxel, Pegfilgrastim
Carboplatin, Cisplatin, Etoposide, Filgrastim, Ifosfamide, Paclitaxel, Pegfilgrastim
Study Staff
- Thomas Powles (Study Coordinator), Barts Health NHS Trust - St. Bartholomew'S Hospital, London
- Egle Venslovaite (Project Manager), EORTC Headquarters, Brussels
- Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
- Ionela Stanciu (Clinical Operations Manager), EORTC Headquarters, Brussels
- Bart Meulemans (Data Manager), EORTC Headquarters, Brussels
- Anna Fleming (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Zara Nasir (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Laurens Vinckier (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Katheline Vander Heggen (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
- Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
- Salvatore Mazza (Lead CRA), EORTC Headquarters, Brussels
- Ilse Coppens (Clinical Operations Assistant), EORTC Headquarters, Brussels
Type of cancer
- Testicular
Participating groups
- EORTC Genito-Urinary Cancers Group
- UNICANCER
- Cancer Trials Ireland
- Alliance
- Institute of Cancer Research - Clinical Trials & Statistics Unit
- The Australian and New Zealand Urogenital and Prostate
Recruiting centers
- 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, 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/Harvard Cancer Center (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)
- Gemeinschaftsklinikum Mittelrhein gGmbH (Koblenz, Germany)
- Greenville Health System Cancer Institute-Eastside (Greenville, United States of America)
- Gustave Roussy (VILLEJUIF 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)
- ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
- IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy)
- Inselspital (Bern, Switzerland)
- Institut Jules Bordet (Anderlecht, Belgium)
- Institut Paoli-Calmettes (MARSEILLE CEDEX 09, 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)
- M D Anderson Cancer Center (Houston, United States of America)
- Mayo Clinic (Rochester, United States of America)
- Medical College of Wisconsin (Milwaukee, 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 Cancer Center (Columbus, United States of America)
- Peter Maccallum Cancer Institute (Melbourne, Australia)
- Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
- 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)
- The Christie NHS Foundation Trust (Manchester, United Kingdom)
- The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
- 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 (TUD) (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 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)
Protocol summary
NCT number
NCT02375204