Clinical Trial Details

EORTC-55994-GCG

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Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa > 4 cm or IIb cervical cancer.

Study documentation Publications

Trial Status Closed to Patient Entry
Dates Date of activation: 19-Mar-2002
Date Step1 close: 01-Jul-2014
Data management at EORTC Yes
Design Phase 3
Randomized open
Targeted Sample size EORTC Groups: 625 - All Groups: 625
Treatment Radiotherapy, Surgery, Drug
Cisplatin
Study Staff Stefano Greggi (Study Coordinator) , Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli
Gemma Kenter (Study Coordinator) , Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam
Fabio Landoni (Study Coordinator) , Istituto Europeo di Oncologia, Milano
Roxana Albu (Regulatory Affairs Manager) roxana.albu (at) eortc.be, EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Trial Assistant) christine.bourguignon (at) eortc.be, EORTC Headquarters, Brussels
Corneel Coens (Statistician) corneel.coens (at) eortc.be, EORTC Headquarters, Brussels
Eleonora De Maio (Clinical Research Physician) eleonora.demaio (at) eortc.be, EORTC Headquarters, Brussels
Maarten De Rouck (Data Manager) maarten.derouck (at) eortc.be, EORTC Headquarters, Brussels
Jelena Laverty (Regulatory Affairs Administrator) jelena.laverty (at) eortc.be, EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) sara.meloen (at) eortc.be, EORTC Headquarters, Brussels
Ellen Peeters (Project Manager) ellen.peeters (at) eortc.be, EORTC Headquarters, Brussels
Type of cancer Cervical
Participating groups EORTC Gynecological Cancer Group
Participating centers Academisch Medisch Centrum - Universiteit van Amsterdam (Amsterdam, Netherlands) - Inst. 342
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Gynecologic Oncology Ospedale S.Anna and University of Turin (Torino, Italy) - Inst. 712
Azienda Ospedaliera Ordine Mauriziano di Torino (Torino, Italy) - Inst. 3902
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) - Inst. 215
Centre Hospitalier Regional De La Citadelle (Liege, Belgium) - Inst. 145
Centre Regional Francois Baclesse (Caen, France) - Inst. 206
Erasmus MC Cancer Institute - location Daniel den Hoed (Rotterdam, Netherlands) - Inst. 302
Hospitais Da Universidade De Coimbra (Coimbra, Portugal) - Inst. 5900
Hospital Universitario San Carlos (Madrid, Spain) - Inst. 366
Istituto Europeo di Oncologia (Milano, Italy) - Inst. 3869
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (Napoli, Italy) - Inst. 3870
Kaiser Franz Josef Spital (Vienna, Austria) - Inst. 822
Leiden University Medical Centre (Leiden, Netherlands) - Inst. 310
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom) - Inst. 7039
Medical University Of Gdansk (Gdansk, Poland) - Inst. 551
Medical University of Graz (Graz, Austria) - Inst. 908
Medisch Spectrum Twente (Enschede, Netherlands) - Inst. 317
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) - Inst. 6982
Oslo University Hospital - Radiumhospitalet (Oslo, Norway) - Inst. 841
Ospedale Di Circolo E Fondazione Macchi (Varese, Italy) - Inst. 715
Ospedale San Gerardo Vecchio (Monza, Italy) - Inst. 775
Queen Elizabeth The Queen Mother Hospital (Margate (kent), United Kingdom) - Inst. 7095
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) - Inst. 304
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147
Universitair Medisch Centrum - Academisch Ziekenhuis (Utrecht, Netherlands) - Inst. 306
Universitair Ziekenhuis Antwerpen (Edegem, Belgium) - Inst. 117
Vrije Universiteit Medisch Centrum (Amsterdam, Netherlands) - Inst. 308
Protocol summary http://clinicaltrials.gov/ct/show/NCT00039338
NCT number NCT00039338
EudraCT 2008-003396-52