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Randomized Phase III study comparing upfront debulking surgery versus neo-adjuvant chemotherapy in patients with Stage IIIc or IV epithelial ovarian carcinoma.

Study documentation

Trial Status All trial activities ended
Dates Date of activation: 21-Sep-1998
Date Step1 close: 06-Dec-2006
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 704
Treatment Surgery, Drug
Carboplatin, Cisplatin
Study Staff Ignace Vergote (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Kin Jip Cheung (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Corneel Coens (Statistician) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer Ovarian
Participating groups EORTC Gynecological Cancer Group
NCIC Clinical Trial Group
Recruiting centers AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Gynecologic Oncology Ospedale S.Anna and University of Turin (Torino, Italy)
CHRU de Lille (Lille, France)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (Bordeaux, France)
Centre Oscar Lambret (Lille, France)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Coombe Women'S Hospital (Dublin, Ireland)
East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
Erasmus MC Hospital (Rotterdam, Netherlands)
Haukeland Hospital - University Of Bergen (Bergen, Norway)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario San Carlos (Madrid, Spain)
Institut Bergonie (Bordeaux, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
Isala Klinieken (Zwolle, Netherlands)
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom)
Medical University of Graz (Graz, Austria)
NHS Greater Glasgow and Clyde - Western Infirmary (Glasgow, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Onze Lieve Vrouw Gasthuis (Amsterdam, Netherlands)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Queen Elizabeth The Queen Mother Hospital (Margate (Kent), United Kingdom)
Ssk Ankara Maternity & Women'S Hospital (Etlik, Ankara, Turkey)
St. James'S Hospital (Dublin, Ireland)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
University College Hospital (London, United Kingdom)
Centers to be activated Centre Hospitalier Regional De La Citadelle (Liege, Belgium)
IRCCS - Fondazione G. Pascale (Napoli, Italy)
Institut Curie- Hopital de Paris (Paris, France)
Medical University Of Gdansk (Gdansk, Poland)
Mirano General Hospital - Veneto Reggion Ulss 13 (Mirano, Italy)
Ospedale Di Circolo E Fondazione Macchi (Varese, Italy)
Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital (Sheffield, United Kingdom)
Universita Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia (Brescia, Italy)
University Hospital Motol (Prague, Czech Republic)
ZNA Middelheim (Antwerpen, Belgium)
Protocol summary
NCT number NCT00003636
Financial Support EORTC HQ