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

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
  • 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

EudraCT