Clinical Trial Details

EORTC-55041-GCG

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A randomized, multicentre, phase III study of Erlotinib versus observation in patients with no evidence of disease progression after first line, platinum-based chemotherapy for high-risk Stage I and Stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer

Study documentation Publications

Trial Status All trial activities ended
Dates Date of activation: 22-Sep-2005
Date Step1 close: 19-Feb-2008
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 560 - All Groups: 830
Treatment Drug
Erlotinib
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
Arbeitsgemeinschaft Gynaekologische Onkologie
Australia & New Zealand Gynaecological Oncology Group
Groupe d'Invest. Nationaux pour Etude Cancers Ovariens
Association de Recherche sur les Cancers Gynecologiques
Mario Negri Gynecologic Oncology Group
Recruiting centers AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
Assistance Publique - Hopitaux de Paris - Hotel-Dieu De Paris (Paris, France)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Gynecologic Oncology Ospedale S.Anna and University of Turin (Torino, Italy)
Bezirkskrankenhaus Kufstein (Kufstein, Austria)
Bronglais General Hospital (Aberystwyth, United Kingdom)
Buckinghamshire Healthcare - Stoke Mandeville Hospital (Aylesbury, United Kingdom)
CH de Valence (Valence, France)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU de Limoges - Hopital Dupuytren (Limoges, France)
CHU de Lyon - Hopital Lyon Sud (Pierre-Benite (Lyon), France)
CHU de Tours - Hopital Bretonneau (Tours, France)
Calvary Mater Newcastle (Waratah, Australia)
Centre Antoine Lacassagne (Nice, France)
Centre Eugene Marquis (Rennes, France)
Centre Francois Baclesse (CLCC) (Caen, France)
Centre Henri Becquerel (Rouen, France)
Centre Hospitalier Avignon (Avignon, France)
Centre Hospitalier Bretagne Sud - Site du Scorff (Lorient, France)
Centre Hospitalier De Bourg-En-Bresse (Bourg-En-Bresse, France)
Centre Hospitalier De Chambery (Chambery Cedex, France)
Centre Hospitalier Departemental Vendee (La Roche Sur Yon, France)
Centre Hospitalier General (Brive, France)
Centre Hospitalier General Robert Ballanger (Aulnay Sous Bois, France)
Centre Hospitalier Regional De La Citadelle (Liege, Belgium)
Centre Hospitalier Regional De La Citadelle (Liege, Belgium)
Centre Hospitalier Universitaire De Poitiers (Poitiers, France)
Centre Hospitalier de Versailles - Hopital Andre Mignot (Le Chesnay, France)
Centre Hospitalier de l'Agglomeration Montargeoise (Amilly-Montargis, France)
Centre Jean Perrin (Clermont-Ferrand, France)
Centre Leon Berard (Lyon, France)
Centre Medico-Chirurgical Foch (Suresnes, France)
Centre d'Oncologie de Gentilly (Nancy, France)
Centro Di Riferimento Oncologico (Aviano, Italy)
Centro Hospitalar e Universitario de Coimbra (Coimbra, Portugal)
Christchurch Hospital (Christchurch, New Zealand)
City Hospital (Birmingham, United Kingdom)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Clinique Du Mail (Grenoble, France)
Clinique Hartmann (Neuilly-Sur-Seine, France)
Clinique Pasteur (Evreux, France)
Clinique Tivoli (Bordeaux, France)
Clinique Victor Hugo - Centre Jean Bernard (Le Mans, France)
East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
Erasmus MC Hospital (Rotterdam, Netherlands)
Frankston Hospital (Frankston, Australia)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Groupe Hospitalier Paris Saint-Joseph - Hopital Saint Joseph (Paris, France)
Heatherwood &Wexham Park Hospital (Slough, Berkshire, United Kingdom)
Hopital De Jolimont (Haine St Paul, Belgium)
Hopital De Montlucon (Montlucon, France)
Hopital Louis Pasteur (Colmar, France)
Hopital Louis Pasteur Chartre (Le Coudray, France)
Hopital Nord Franche-Comte - Site de Montbeliard (Montbeliard, France)
Hopitaux Universitaires de Strasbourg - Hôpital civil (Strasbourg, France)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario San Carlos (Madrid, Spain)
Hospital Virgen De La Salud (Toledo, Spain)
Hospital prive du Confluent - Centre Catherine de Sienne (Nantes, France)
Huddersfield Royal Infirmary (Huddersfield, United Kingdom)
Institut Bergonie (Bordeaux, France)
Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Institut Curie- Hopital de Paris (Paris, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
Institut de Cancerologie de la Loire Lucien Neuwirth (Saint Priest en Jarez, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
Institut du Cancer de Montpellier (Montpellier, France)
Ipswich Hospital Nhs Trust (Ipswich, Suffolk, United Kingdom)
Istituto Europeo di Oncologia (Milano, Italy)
Krankenhaus Der Barmherzigen Brueder (Graz, Austria)
Landeskrankenhauses Leoben, Abt (Leoben, Austria)
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom)
Manning Base Hospital (Taree, Australia)
Medical University of Graz (Graz, Austria)
Murray Valley Private Hospital (Wodonga, Australia)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
Newcastle Hospitals NHS Trust - Campus for Ageing and Vitality (Newcastle-Upon-Tyne, United Kingdom)
Norfolk And Norwich Hospital (Norwich, United Kingdom)
North Staffordshire Hospital-Ssotp Clinics (Stoke On Trent, United Kingdom)
Onze Lieve Vrouw Gasthuis (Amsterdam, Netherlands)
Ospedale Di Circolo E Fondazione Macchi (Varese, Italy)
Ospedale Niguarda Ca Granda (Milano, Italy)
Ospedale Riuniti Villa Sofia-Cervello (Palermo, Italy)
Ospedale San Gerardo Vecchio (Monza, Italy)
Palmerston North Hospital (Palmerston, New Zealand)
Polyclinique Bordeaux-Nord Aquitaine (Bordeaux, France)
Prince Of Wales Hospital (Randwick - Sydney, Australia)
Queen Elizabeth The Queen Mother Hospital (Margate (Kent), United Kingdom)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Royal Shrewsbury Hospital (Shrewsbury, United Kingdom)
Royal United Hospitals Bath NHS Foundation Trust - Royal United Hospital (Bath, United Kingdom)
Royal Women's Hospital (Carlton, Australia)
Sir Charles Gairdner Hospital (Nedlands, Australia)
St. Mary'S Hospital (Portsmouth Hants, United Kingdom)
The Canberra Hospital (Garran (woden), Australia)
The James Cook University Hospital (Middlesbrough, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
University College Hospital (London, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
University Medical Center Groningen (Groningen, Netherlands)
Velindre NHS Trust - Velindre Cancer Centre (Cardiff, United Kingdom)
Wels Hospital (Wels, Austria)
Wiener Gesundheidsverbund - Klinik Hietzing (Vienna, Austria)
Yeovil District Hospital (Yeovil, United Kingdom)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Alexandra Hospital (Redditch, United Kingdom)
Amersham Hospital (Amersham, United Kingdom)
CH de Mulhouse - Hopital Emile Muller-Moenchsberg (Mulhouse, France)
Cabinet Privé du Docteur Flesch (Dijon, France)
Center Cancer Du Grand Montpellier (Montpellier, France)
Centre Clinique de la Porte Saint Cloud (Boulogne, France)
Centre Hospitalier D'Aix-En-Provence (Aix-En-Provence, France)
Centre Hospitalier Rene Dubos (Pontoise, France)
Centre Hospitalier de Montelimar (Montelimar, France)
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
Flinders Medical Centre (Bedford Park, Australia)
Furness General Hospital (Barrow-in-Furness, Cumbria, United Kingdom)
George Elliot Hospital (Nuneaton, Warwickshire, United Kingdom)
Glan Clwyd District General Hospital (Rhyl, Denbighshire, United Kingdom)
Good Hope Hospital (Sutton Coldfield, United Kingdom)
Hanusch Krankenhaus (Vienna, Austria)
Hereford County Hospital (Hereford, United Kingdom)
Hopital Americain (Neuilly sur Seine, France)
Hopital Europeen (Marseille, France)
Hopital de La Timone (APHM) (Marseille, France)
IRCCS - Istituto Oncologico Veneto (Padova, Italy)
Institut Sainte Catherine (Avignon, France)
Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
James Paget Hospital (Great Yarmouth, United Kingdom)
King's Mill Hospital (Sutton-in-Ashfield, Nottinghamshire, United Kingdom)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Medical University Of Gdansk (Gdansk, Poland)
North West Wales Nhs Trust - Bangor Hospital (Gwynedd - Bangor, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
Royal Devon And Exeter Hospital (Exeter - Devon, United Kingdom)
Royal Lancaster (Lancaster, United Kingdom)
Scarborough Hospital (Scarborough, North Yorkshire, United Kingdom)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
Ssk Ankara Maternity & Women'S Hospital (Etlik, Ankara, Turkey)
St George's Hospital NHS Trust (London, United Kingdom)
St Mary'S Hospital (MFT) (Manchester, United Kingdom)
Staffordshire General Hospital (Stafford, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Royal Surrey County Hospital NHS Foundation Trust (Guildford, United Kingdom)
United Lincolnshire Hospitals NHS Trust-Lincoln County Hospital (Lincoln, United Kingdom)
Universita Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia (Brescia, Italy)
University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (Coventry, United Kingdom)
University Hospitals of Derby and Burton NHS Foundation Trust - London Road Community Hospital (Derby, United Kingdom)
Warwick Hospital (Warwick, United Kingdom)
Worthing Hospital (Worthing - West Sussex, United Kingdom)
Wycombe Hospital (High Wycombe, United Kingdom)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00263822
NCT number NCT00263822
EudraCT 2004-004333-34
Financial Support Educational Grant