Spots Global Cancer Trial Database for Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
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Trial Identification
Brief Title: Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Official Title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Study ID: NCT01166737
Study Description
Brief Summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.
Detailed Description: A predictive score identifying patients who might achieve a complete resection is deemed necessary to select the right patients for a prospective trial on cytoreductive surgery in relapsed ovarian cancer. Study centres are selected due to their surgical experience in ovarian cancer and/or participation in prior surgical trials in this field. Patients who matched eligibility criteria were allocated randomly 1:1 prospectively to cytoreductive surgery followed by platinum based combination chemotherapy or to platinum based combination chemotherapy alone .
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe, Graz, , Austria
Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe, Innsbruck, , Austria
Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde, Wien, , Austria
Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung, Wien, , Austria
UZ Leuven, Leuven, , Belgium
Zhejiang Cancer Hospital, Gynecology Oncology, Hangzhou, , China
Fudan University Cancer Hospital, Gynecologic Oncology, Shanghai, , China
Fudan University Zhongshan Hospital, Obstetrics and Gynecology, Shanghai, , China
Suzhou Municipal Hospital, Gynecologic and Obstetrics, Suzhou, , China
Aalborg Hospital, Aalborg, , Denmark
Aarhus University Hospital,Oncology, Aarhus, , Denmark
Ringshospitalet Copenhagen University Hospital; Oncology, Copenhagen, , Denmark
Herlev Hospital, Herlev, , Denmark
Odense University Hospital, Gynaecology and Obstetrics, Odense, , Denmark
Institut Bergonié, Gynecology, Bordeaux, , France
Centre Francois Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Antoine Lacassagne, Nice, , France
Hôpital Européen Georges Pompidou, Paris, , France
Hôpital Tenon, Paris, , France
Insitut Jean Godinot, Service Rubis - Oncologie Médicale, Reims, , France
Centre Eugène Marquis, Rennes, , France
Centre Hospitalier Universitaire Charles-Nicolle, Rouen, , France
Centre Henri Becquerel, Rouen, , France
Centre René Gauducheau, Saint-Herblain, , France
Centre Claudius Regaud, Toulouse, , France
Hochtaunus-Kliniken gGmbH, Frauenklinik, Bad Homburg, , Germany
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe, Dresden, , Germany
Evangelisches Krankenhaus, Frauenklinik, Düsseldorf, , Germany
Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie, Düsseldorf, , Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie, Essen, , Germany
Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe, Frankfurt am Main, , Germany
Universitätsklinikum Freiburg, Frauenklinik, Freiburg, , Germany
Klinikum Fürth, Frauenklinik Nathanstift, Fürth, , Germany
Gynecologic Clinic of the Ernst-Moritz-Arndt-University, Greifswald, , Germany
Georg-August-Universität Göttingen, Universitäts-Frauenklinik, Göttingen, , Germany
Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe, Hannover, , Germany
Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe, Kempten, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe, Kiel, , Germany
Klinikum Konstanz, Frauenklinik, Konstanz, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, , Germany
Universitätsklinikum Mainz, Frauenklinik, Mainz, , Germany
Klinikum Dritter Orden, Gynäkologie und Geburtshilfe, München, , Germany
Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, München, , Germany
Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik, Ravensburg, , Germany
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg, Regensburg, , Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik, Schweinfurt, , Germany
Universitätsklinikum, Universitätsfrauenklinik, Ulm, , Germany
Ammerland-Klinik GmbH, Frauenklinik, Westerstede, , Germany
HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie, Wiesbaden, , Germany
Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica, Aviano, , Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, , Italy
Istituto Europeo di Oncologia, Divisione di Ginecologia, Milan, , Italy
Istituto Nazionale Tumori di Napoli, Gynecologic Oncology, Naples, , Italy
Seoul National University Hospital, Department of Obstetrics and Gynecology, Seoul, , Korea, Republic of
Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology, Oslo, , Norway
ICO Badalona - H. U. Germans Trias i Pujol, Badalona, , Spain
Hospital de la Santa Creu i Sant Pau, Oncology, Barcelona, , Spain
Hospital Clinic Barcelona, Oncology, Barcelona, , Spain
ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona, Girona, , Spain
Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology, Hospitalet de Llobregat, , Spain
Hospital Son Llàtzer, Oncology, Palma de Mallorca, , Spain
Hospital de Navarra, Oncology, Pamplona, , Spain
Fundación Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Universitari i Politècnic la Fe, Oncology, Valencia, , Spain
Linköping University Hospital, Department of Obstetrics and Gynecology, Linköping, , Sweden
Karolinska University Hospital, Oncology, Stockholm, , Sweden
Birmingham City Hospital, Cancer Research Team, Birmingham, , United Kingdom
Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology, Cambridge, , United Kingdom
Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre, Gateshead, , United Kingdom
Royal Surrey Country Hospital,St Lukes Cancer Centre, Guildford, , United Kingdom
Lincoln County Hospital, Oncology, Lincoln, , United Kingdom
St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre, London, , United Kingdom
University College London Hospital, Cancer clinical trails unit, London, , United Kingdom
Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House, London, , United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology, London, , United Kingdom
Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology, Manchester, , United Kingdom
Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre, Margate, , United Kingdom
Northampton General Hospital, Gynaecological Oncology, Northampton, , United Kingdom
East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology, Northwood, , United Kingdom
Norfolk & Norwich University Hospital,Obstetrics & Gynaecology, Norwich, , United Kingdom
Nottingham University Hospital, City Campus, Oncology, Nottingham, , United Kingdom
Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre, Sheffield, , United Kingdom
Princess Anne Hospital, gynaecology, Southampton, , United Kingdom
New Cross Hospital,Oncology/Gynaecology, Wolverhampton, , United Kingdom
Contact Details
Name: Philipp Harter, MD
Affiliation: AGO Study Group
Role: PRINCIPAL_INVESTIGATOR
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