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
| 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 |
Christine Bourguignon (Clinical Operations Assistant) , 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 |
APHP Centre - Univ de Paris Cite - Hopital Hotel-Dieu (PARIS, France) AZ Groeninge – Oncology Centre (Kortrijk, Belgium) AZ Groeninge – Oncology Centre (Kortrijk, Belgium) 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- Ospedale Niguarda CA' Granda (Milano, Italy) Azienda Ospedaliera- Ospedale Riuniti Villa Sofia-Cervello (Palermo, Italy) Bezirkskrankenhaus Kufstein (Kufstein, Austria) Bronglais General Hospital (Aberystwyth, United Kingdom) Buckinghamshire Healthcare - Stoke Mandeville Hospital (Aylesbury, United Kingdom) CH de Valence (VALENCE CEDEX 9, France) CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium) CHU Mont Godinne - UCL Namur (Yvoir, Belgium) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France) CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, France) CHU de Tours - Hopital Bretonneau (Tours, France) CLCC - Jean Perrin (CLERMONT FERRAND , France) Calvary Mater Newcastle (Waratah, Australia) Centre Antoine Lacassagne (NICE CEDEX 2, France) Centre Eugene Marquis (RENNES CEDEX, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Henri Becquerel (ROUEN CEDEX, France) Centre Hospitalier Avignon (AVIGNON CEDEX 9, France) Centre Hospitalier Bretagne Sud - Site du Scorff (LORIENT CEDEX, France) Centre Hospitalier De Bourg-En-Bresse (Bourg-En-Bresse, France) Centre Hospitalier Departemental Vendee (LA ROCHE SUR YON CEDEX 9, France) Centre Hospitalier General (Brive, France) Centre Hospitalier General Robert Ballanger (Aulnay Sous Bois, France) Centre Hospitalier Pasteur (COLMAR CEDEX, France) Centre Hospitalier Regional De La Citadelle (Liege, Belgium) Centre Hospitalier Regional De La Citadelle (Liege, Belgium) Centre Hospitalier Universitaire De Poitiers (POITIERS CEDEX, France) Centre Hospitalier de Versailles - Hopital Andre Mignot (LE CHESNAY CEDEX, France) Centre Hospitalier de l'Agglomeration Montargeoise (Amilly-Montargis, France) Centre Leon Berard (Lyon, France) Centre Medico-Chirurgical Foch (Suresnes, France) Centro Di Riferimento Oncologico (Aviano, Italy) Centro Hospitalar e Universitario de Coimbra (Coimbra, Portugal) Christchurch Hospital - Canterbury regional Cancer and Haematology service (Christchurch , New Zealand) City Hospital (Birmingham, United Kingdom) Clatterbridge Cancer Center - 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 Montlucon (MONTLUCON CEDEX, France) Hopital Louis Pasteur Chartre (Le Coudray, France) Hopital Nord Franche-Comte - Site de Montbeliard (MONTBELIARD CEDEX, France) Hopitaux Universitaires de Strasbourg - Hôpital civil (STRASBOURG CEDEX, 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 CEDEX 2, France) Huddersfield Royal Infirmary (Huddersfield, United Kingdom) Institut Bergonie (Bordeaux, France) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Institut Jules Bordet (Anderlecht, 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) - Angers (ANGERS CEDEX 02, France) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, 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 San Gerardo Vecchio (Monza, Italy) Palmerston North Hospital (Palmerston, New Zealand) Polyclinique Bordeaux-Nord Aquitaine (BORDEAUX CEDEX, France) Polyclinique De Gentilly - Centre d'Oncologie (Nancy, 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) Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria) Universitaetsklinikum Wien - AKH unikliniken (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 (Worcestershire, United Kingdom) Amersham Hospital (Buckinghamshire , United Kingdom) Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Brescia, Italy) CH de Mulhouse - Hopital Emile Muller-Moenchsberg (MULHOUSE CEDEX 1, 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 CEDEX 5, France) IRCCS - Istituto Oncologico Veneto (Padova, Italy) Institut Sainte Catherine (AVIGNON CEDEX 9, France) Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal) James Paget Univesity Hospitals NHS Foundation Trust (Norfolk, 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 University Healthcare (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 University Hospital NHS Trust Foundation (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) 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 (Buckinghamshire , United Kingdom) |
| Protocol summary | http://clinicaltrials.gov/study/NCT00263822 |
| NCT number | NCT00263822 |
| EudraCT | 2004-004333-34 |
| Financial Support | Educational Grant |
