Clinical Trial Details

EORTC-55102-GCG

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A phase III Trial of postoperative chemotherapy or no further treatment for patients with stage I-II medium or high risk endometrial cancer.

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 17-Apr-2013
Date Step1 close: 10-May-2019
Data management at EORTC No
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 255 - All Groups: 678
Treatment Drug
Carboplatin, Paclitaxel
Study Staff Mansoor Raza Mirza (Study Coordinator) , Rigshospitalet, Copenhagen
Corneel Coens (Statistician) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Ellen Peeters (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Endometrium
Participating groups EORTC Gynecological Cancer Group
Central & Eastern European Gynecologic Oncology Group
Grupo Espanol de Investigacion del Cancer de Ovario
Multicenter Italian Trials in Ovarian Cancer
Mario Negri Gynecologic Oncology Group
Danish Gynaecological Cancer Group
Belgian Gynaecological Oncology Group
Nord-Ostdeutsche Gesellschaft fuer Gynaekologische Onkologie
Israeli Society of Gyne Oncology
Recruiting centers AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
AZ Maria Middelares (Gent, Belgium)
Aalborg University Hospital (Aalborg, Denmark)
Aarhus University Hospital (Aarhus, Denmark)
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Azienda Ospedaliera Ordine Mauriziano di Torino (Torino, Italy)
Bseobecna Fakultni Nemocnice V Praze (Prague, Czech Republic)
C.H.U. Sart-Tilman (Liege, Belgium)
CHU Helora Ambroise Pare (Mons, Belgium)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
Centre Hospitalier Regional De La Citadelle (Liege, Belgium)
Centro Oncológico MD Anderson (Madrid, Spain)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
E. Wolfson Medical Center (Holon, Israel)
Erasmus MC (Rotterdam, Netherlands)
Fakultní nemocnice Ostrava (Ostrava-Poruba, Czech Republic)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Hillel Yaffe Centre (Hadera, Israel)
Hopital De Libramont (Libramont, Belgium)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital Regional Universitario - Materno & Infantil (Malaga, Spain)
Hospital Son Llatzer (Palma De Mallorca, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario Infanta Sofía (Madrid, Spain)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hospital Universitario Reina Sofia (Cordoba, Spain)
Hospital Universitario San Carlos (Madrid, Spain)
Hospital Universitario Y Politecnico La Fe (Valencia, Spain)
Hospital Virgen De La Salud (Toledo, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
IRCCS - Fondazione G. Pascale (Napoli, Italy)
IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy)
Institut Jules Bordet (Anderlecht, Belgium)
Istituto Europeo di Oncologia (Milano, Italy)
Jan Yperman ziekenhuis (Ieper, Belgium)
Jyvaskyla Central Hospita (Jyvaskyla, Finland)
Karolinska University Hospital, location Solna (Stockholm Solna, Sweden)
Kliniken Essen-Mitte (Essen, Germany)
Kliniken Suedostbayern AG-Klinikum Traunstein (Traunstein, Germany)
Kuopio University Hospital (Kuopio, Finland)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Linkoping University Hospital (Linkoping, Sweden)
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
Norfolk And Norwich Hospital (Norwich, United Kingdom)
Norrlands Universitetssjukhus (Umea, Sweden)
Northampton General Hospital NHS Trust (Northampton, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Odense University Hospital (Odense C, Denmark)
Oulu University Hospital (Oulu, Finland)
Parc Tauli Hospital Universitari (Sabadell Barcelona, Spain)
Queen Elizabeth The Queen Mother Hospital (Margate (Kent), United Kingdom)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Rigshospitalet (Copenhagen, Denmark)
Sahlgrenska Universitetssjukhuset (Goteborg, Sweden)
Sygehus Lillebaelt - Vejle Sygehus (Vejle, Denmark)
Tampere University Hospital (Tampere, Finland)
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)
Turku University Central Hospital (Turku, Finland)
Universitaetsklinikum Ulm-Michelsberg (Ulm, Germany)
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Hospital Hradec Kralove (Hradec Kralove, Czech Republic)
Ziekenhuis Oost Limburg (Genk, Belgium)
Protocol summary http://clinicaltrials.gov/study/NCT01244789
NCT number NCT01244789
EudraCT 2010-023081-52
Financial Support EORTC Group
Academic Fund