EORTC-55116-62114-GCG-STBSG

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A Phase III Randomized Trial of Gemcitabine plus Docetaxel followed by Doxorubicin v. observation for uterus-limited, High Grade Uterine Leiomyosarcoma

Study documentation

Trial Status	All trial activities ended
Dates	Date of activation: 15-Dec-2014 Date Step1 close: 20-Sep-2016
Data management at EORTC	No
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 72 - All Groups: 216
Treatment	Drug Docetaxel, Doxorubicin, Gemcitabine
Study Staff	Petronella Beatrix Ottevanger (Study Coordinator) , Radboud University Medical Center Nijmegen, Nijmegen Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer	Uterine
Participating groups	EORTC Gynecological Cancer Group EORTC Soft Tissue and Bone Sarcoma Group National Cancer Research Institute - Gyneco Cancer Group National Cancer Research Institute - Sarcoma Group Gynaecological Oncology Group
Recruiting centers	Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Leon Berard (Lyon, France) Hospital Universitario San Carlos (Madrid, Spain) Hospital prive du Confluent - Centre Catherine de Sienne (NANTES CEDEX 2, France) Institut Bergonie (Bordeaux, France) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) The Christie NHS Foundation Trust (Manchester, United Kingdom) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University College Hospital (London, United Kingdom) University Medical Center Groningen (Groningen, Netherlands)
Centers to be activated	Belfast City Hospital (Belfast, United Kingdom) Hospital Universitario 12 De Octubre (Madrid, Spain) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) Medizinische Hochschule Hannover (Hannover, Germany) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) University Hospital Southampton NHS Foundation Trust - Royal South Hants Hospital (Southampton, United Kingdom) University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital (Derby, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT01533207
NCT number	NCT01533207
EudraCT	2012-002852-17
Financial Support	EORTC Group External Grant