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| Name | Class |
|---|---|
| Arbeitsgemeinschaft Gynaekologische Onkologie Austria | OTHER |
| ARCAGY/ GINECO GROUP | OTHER |
| Australia New Zealand Gynaecological Oncology Group | OTHER |
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Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Patients receive bevacizumab 15 mg/kg iv on day 1 followed by gemcitabine 1000mg/m² iv on day 1 & 8 and carboplatin AUC4 iv on day 1 every 3 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities. | |
| Research Arm | Experimental | Patients receive bevacizumab 10 mg/kg iv on day 1 & 15 followed by PLD 30mg/m² iv on day 1 carboplatin AUC4 iv on day 1 every 4 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug |
| ||
| PLD |
| Measure | Description | Time Frame |
|---|---|---|
| investigator-determined progression-free survival | every 12 weeks until progression or up to 30 months (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| biological progression-free survival by serum CA 125 | every 3 weeks until progression or up to 30 months (whichever occurs first) | |
| Health related Quality of Life (QoL) | Baseline and then every 12 weeks until investigator-determined progresssion-free survival and thereafter at every visit for th 5-years follow-up or death (whichever occurs first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacobus Pfisterer, PhD MD | AGO Study Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bankstown-Lidcombe Hospital | Bankstown | Australia | ||||
| Chris O'Brien Lifehouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32305099 | Result | Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marme F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16. |
| Label | URL |
|---|---|
| Homepage of AGO Study Group | View source |
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| Scottish Gynaecological Cancer Study Group |
| OTHER |
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|
| Bevacizumab | Biological |
|
| Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions | every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later) |
| Overall Survival | every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months |
| Camperdown |
| Australia |
| NCCI - Coffs Harbour Hospital | Coffs Harbour | Australia |
| The Townsville Hospital | Douglas | Australia |
| Peninsula Health - Frankston Hospital | Frankston | Australia |
| Andrew Love Cancer Centre Geelong | Geelong | Australia |
| Royal Brisbane & Women's Hospital | Herston | Australia |
| Royal Hobart Hospital | Hobart | Australia |
| St. George Hospital | Kogarah | Australia |
| ICON Cancer Care Centre | Milton | Australia |
| Nambour General Hospital | Nambour | Australia |
| Sir Charles Gairdner | Nedlands | Australia |
| North Coast Cancer Institute | Port Macquarie | Australia |
| Royal Hospital for Women | Randwick | Australia |
| Mater Adult Hospital | South Brisbane | Australia |
| Gold Coast University Hospital | Southport | Australia |
| Royal North Shore Hospital | St Leonards | Australia |
| St. John of God Hospital | Subiaco | Australia |
| Border Medical Oncology | Wodonga | Australia |
| MUG-Universitätsklinik für Frauenheilkunde Graz | Graz | Austria |
| MUI-Universität für Frauenheilkunde | Innsbruck | Austria |
| AKH Linz | Linz | Austria |
| BHS Linz | Linz | Austria |
| SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe | Salzburg | Austria |
| MUW-AKH Wien | Vienna | Austria |
| UZ Leuven | Leuven | Belgium |
| ICO Paul Papin | Angers | France |
| Institut Sainte Catherine | Avignon | France |
| Centre Hospitalier de Blois | Blois | France |
| Clinique Tivoli | Bordeaux | France |
| Polyclinique Bordeaux Nord | Bordeaux | France |
| Centre Francois Baclesse | Caen | France |
| Centre Hospitalier William Morey | Chalon-sur-Saône | France |
| Centre Hospitalier de Cholet | Cholet | France |
| Hôpital Antoine Béclère | Clamart | France |
| Centre Jean Perrin | Clermont-Ferrand | France |
| Centre Hospitalier la Dracénie | Draguignan | France |
| Centre Hospitalier Général de Gap | Gap | France |
| Groupe Hospitalier Mutualiste de Grenoble | Grenoble | France |
| Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble | Grenoble | France |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | France |
| Institut d'Oncologie Hartmann | Levallois-Perret | France |
| Centre Oscar Lambret | Lille | France |
| Hôpital Privé Clairval | Marseille | France |
| Institute Paoli Clamettes | Marseille | France |
| Hôpital Mercy | Metz | France |
| Hôpital de Mont-de-Marsan | Mont-de-Marsan | France |
| ICM Val d'Aurelle | Montpellier | France |
| Hôpital Emile Muller | Mulhouse | France |
| Centre d'Oncologie de Gentilly | Nancy | France |
| Centre Catherine de Sienne | Nantes | France |
| Centre Hospitalier Régional d'Orleans | Orléans | France |
| Group Hospitalier Saint-Joseph | Paris | France |
| Centre Catalan d'Oncologie | Perpignan | France |
| Clinique Francheville | Périgueux | France |
| Centre Eugène Marquis | Rennes | France |
| HôpitauxDrôme Nord - Site de Ramons | Romans-sur-Isère | France |
| Centre Henri Becquerel | Rouen | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | France |
| ICO Centre René Gauducheau | Saint-Herblain | France |
| Clinique Mutualiste de l'Estuaire, Cité Sanitaire | Saint-Nazaire | France |
| Centre Paul Strauss | Strasbourg | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| Centre Hospitalier de Thonon-les-Bains | Thonon-les-Bains | France |
| Clinique Pasteur | Toulouse | France |
| Clinique Saint Jean du Languedoc | Toulouse | France |
| Centre Hospitalier Bretagne Atlantique | Vannes | France |
| Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie | Villeneuve-d'Ascq | France |
| Kreisklinik Altötting-Burghausen | Altötting | Germany |
| Klinikum St. Marien | Amberg | Germany |
| Klinikum Aschaffenburg | Aschaffenburg | Germany |
| Klinikum Augsburg | Augsburg | Germany |
| Hochtaunus-Klinik | Bad Homburg | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | Germany |
| Praxisklinik Krebsheilkunde für Frauen | Berlin | Germany |
| Augusta-Kranken-Anstalt Bochum | Bochum | Germany |
| Johanniter-Krankenhaus | Bonn | Germany |
| Medizinisches Zentrum Bonn-Friedensplatz | Bonn | Germany |
| Schwerpunktpraxis für Onkologie / Hämatologie | Bottrop | Germany |
| Städtisches Klinikum Brandenburg | Brandenburg | Germany |
| Gynäkologisch-Onkologische Gemeinschaftspraxis | Braunschweig | Germany |
| DIAKO Ev. Diakonie-Krankenhaus | Bremen | Germany |
| Gynaekologicum Bremen | Bremen | Germany |
| Klinikum Bremen-Mitte | Bremen | Germany |
| Klinikum Chemnitz | Chemnitz | Germany |
| St. Elisabeth-Krankenhaus Hohenlind | Cologne | Germany |
| Universitätsklinikum Köln | Cologne | Germany |
| Klinikum Darmstadt | Darmstadt | Germany |
| Donau-Isar-Kliniken, Klinikum Deggendorf | Deggendorf | Germany |
| Städtisches Klinikum Dessau | Dessau | Germany |
| Klinikum Dortmund | Dortmund | Germany |
| Onkozentrum Dresden | Dresden | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Germany |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | Germany |
| Kaiserswerther Diakonie, Florence-Nightingale-Krankenhaus | Düsseldorf | Germany |
| Universitätsfrauenklinik Düsseldorf | Düsseldorf | Germany |
| Rottal-Inn-Klinik Eggenfelden | Eggenfelden | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Klinikum Essen Mitte | Essen | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Klinikum Esslingen | Esslingen am Neckar | Germany |
| DIAKO Flensburg | Flensburg | Germany |
| Agaplesion Markus Krankenhaus | Frankfurt | Germany |
| Klinikum Frankfurt Höchst | Frankfurt | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Universitätsfrauenklinik Freiburg | Freiburg im Breisgau | Germany |
| Kreiskrankenhaus Freudenstadt | Freudenstadt | Germany |
| Klinikum Fürth | Fürth | Germany |
| Franziskus-Hospital Harderberg | Georgsmarienhütte | Germany |
| HELIOS-Klinikum Gifhorn | Gifhorn | Germany |
| Onkologische Kooperation Harz | Goslar | Germany |
| Die Frauenarztpraxis in Grafing | Grafing | Germany |
| Universitätsmedizin Greifswald | Greifswald | Germany |
| Universitätsklinikum Halle | Halle | Germany |
| Albertinen Krankenhaus | Hamburg | Germany |
| Marienkrankenhaus Hamburg | Hamburg | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Sana-Klinikum Hameln-Pyrmont | Hamelin | Germany |
| Klinikum Hanau | Hanau | Germany |
| Friederikenstift | Hanover | Germany |
| Gynäkologisch-Onkologische Praxis Hannover | Hanover | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Paracelsus-Klinik | Henstedt-Ulzburg | Germany |
| Praxis Dres. Uleer / Pourfard | Hildesheim | Germany |
| Klinikum Itzehoe | Itzehoe | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| St. Vincentius Kliniken | Karlsruhe | Germany |
| Klinikum Kassel | Kassel | Germany |
| Klinikum Kempten | Kempten | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Germany |
| Zentrum für Gynäkologische Onkologie | Kiel | Germany |
| Klinikum Konstanz | Konstanz | Germany |
| Klinikum Kulmbach | Kulmbach | Germany |
| Asklepios Klinik Lich | Lich | Germany |
| St. Vincenz Krankenhaus | Limburg | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | Germany |
| Onkologische Schwerpunktpraxis Lüneburg | Lüneburg | Germany |
| Klinik St. Marienstift | Magdeburg | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | Germany |
| Universitätsmedizin Mainz | Mainz | Germany |
| Universitätsfrauenklinik Mannheim | Mannheim | Germany |
| Universitätsklinikum Gießen und Marburg | Marburg | Germany |
| Johannes Wesling Klinikum | Minden | Germany |
| Klinikum rechts der Isar | München | Germany |
| LMU München, Frauenklinik Großhadern | München | Germany |
| Rotkreuzklinikum München | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Kliniken des Landkreises Neumarkt | Neumarkt | Germany |
| Lukaskrankenhaus | Neuss | Germany |
| MVZ Nordhausen | Nordhausen | Germany |
| Klinikum Nürnberg | Nuremberg | Germany |
| Klinikum Offenbach | Offenbach | Germany |
| Ortenau-Klinikum | Offenburg | Germany |
| Marienhospital | Osnabrück | Germany |
| St. Vincenz Krankenhaus | Paderborn | Germany |
| Onkologische Praxis Pinneberg | Pinneberg | Germany |
| Harzklinikum Quedlinburg | Quedlinburg | Germany |
| Onkologie Ravensburg | Ravensburg | Germany |
| imland Klinik Rendsburg | Rendsburg | Germany |
| Klinikum am Steinenberg | Reutlingen | Germany |
| Universitätsfrauenklinik Rostock | Rostock | Germany |
| Thüringen-Kliniken | Saalfeld | Germany |
| Caritasklinikum St. Theresia | Saarbrücken | Germany |
| Praxis Dr. med. W. Dietz | Salzgitter | Germany |
| Diakonie-Klinikum Schwäbisch Hall | Schwäbisch Hall | Germany |
| Leopoldina-Krankenhaus | Schweinfurt | Germany |
| HELIOS Kliniken Schwerin | Schwerin | Germany |
| Diakonie Klinikum Jung-Stilling | Siegen | Germany |
| Klinikum Schaumburg, Krankenhaus Stadthagen | Stadthagen | Germany |
| Klinikum Starnberg | Starnberg | Germany |
| g.Sund Gyn. Kompetenzzentrum | Stralsund | Germany |
| Marienhospital Stuttgart | Stuttgart | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | Germany |
| SRH Zentralklinikum Suhl | Suhl | Germany |
| Kreiskrankenhaus "J. Kentmann" | Torgau | Germany |
| Klinikum Traunstein | Traunstein | Germany |
| Klinikum Mutterhaus | Trier | Germany |
| Universitätsklinikum Tübingen | Tübingen | Germany |
| Universitätsfrauenklinik Ulm | Ulm | Germany |
| Praxis Dr. med. W. W. Reiter | Viersen | Germany |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen | Villingen-Schwenningen | Germany |
| Lahn-Dill-Kliniken Wetzlar | Wetzlar | Germany |
| Dr. Horst Schmidt Kliniken | Wiesbaden | Germany |
| St. Josefs Hospital Wiesbaden | Wiesbaden | Germany |
| amO am Klieversberg | Wolfsburg | Germany |
| Klinikum Worms | Worms | Germany |
| Heinrich-Braun-Klinikum | Zwickau | Germany |
| Gwynedd Hospital | Bangor | United Kingdom |
| Velindre Cancer Centre | Cardiff | United Kingdom |
| The Beatson West of Scotland Cancer Center | Glasgow | United Kingdom |
| Glan Clywd Hospital | Rhyl | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C041277 | 1-dodecylpyridoxal |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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