EORTC-55971-GCG

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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	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 CEDEX, France) CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (BORDEAUX CEDEX, France) Centre Oscar Lambret (LILLE CEDEX, France) Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom) Coombe Women and infants University HospitalHospital (Dublin 8, Ireland) East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom) Erasmus MC Hospital (Rotterdam, Netherlands) Helse Bergen HF -Haukeland Hospital - Univ. Hosp (Bergen, Norway) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario San Carlos (Madrid, Spain) Institut Bergonie (Bordeaux, France) Institut Jules Bordet (Anderlecht, 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) 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) 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	Azienda Ospedaliera - Ospedale Di Circolo E Fondazione Macchi (Varese, Italy) Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Brescia, Italy) Centre Hospitalier Regional De La Citadelle (Liege, Belgium) IRCCS - Fondazione G. Pascale (Napoli, Italy) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Medical University Of Gdansk (Gdansk, Poland) Mirano General Hospital - Veneto Reggion Ulss 13 (Mirano, Italy) Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital (Sheffield, United Kingdom) University Hospital Motol (Prague, Czech Republic) ZNA Middelheim (Antwerpen, Belgium)
Protocol summary	http://clinicaltrials.gov/ct/show/NCT00003636
NCT number	NCT00003636
Financial Support	EORTC HQ