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

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 label
Targeted Sample size	EORTC Groups: 625 - All Groups: 625
Treatment	Radiotherapy, Surgery, Drug Cisplatin
Study Staff	Stefano Greggi (Study Coordinator) , IRCCS - Fondazione G. Pascale, Napoli Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Sven Janssen (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer	Cervical
Participating groups	EORTC Gynecological Cancer Group
Recruiting centers	Azienda Ospedaliera - Ospedale Di Circolo E Fondazione Macchi (Varese, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Gynecologic Oncology Ospedale S.Anna and University of Turin (Torino, Italy) Azienda Ospedaliera Ordine Mauriziano di Torino (Torino, Italy) CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Hospitalier Regional De La Citadelle (Liege, Belgium) Centro Hospitalar e Universitario de Coimbra (Coimbra, Portugal) Erasmus MC (Rotterdam, Netherlands) Hospital Universitario San Carlos (Madrid, Spain) IRCCS - Fondazione G. Pascale (Napoli, Italy) Leiden University Medical Centre (Leiden, Netherlands) Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom) Medical University Of Gdansk (Gdansk, Poland) Medical University of Graz (Graz, Austria) Medisch Spectrum Twente (Enschede, Netherlands) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Queen Elizabeth The Queen Mother Hospital (Margate (Kent), United Kingdom) UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands) Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Protocol summary	http://clinicaltrials.gov/study/NCT00039338
NCT number	NCT00039338
EudraCT	2008-003396-52
Financial Support	EORTC Group