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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
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
Angelique Deleersnijder (Regulatory Affairs Manager) , 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
Ellen Peeters (Project Manager) , EORTC Headquarters, Brussels
Type of cancer Cervical
Participating groups EORTC Gynecological Cancer Group
Recruiting centers 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, France)
Centre Francois Baclesse (CLCC) (Caen, 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)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Ospedale Di Circolo E Fondazione Macchi (Varese, Italy)
Queen Elizabeth The Queen Mother Hospital (Margate (Kent), United Kingdom)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Protocol summary
NCT number NCT00039338
EudraCT 2008-003396-52
Financial Support EORTC Group