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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.
Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Lymphadenectomy (LNE) | Procedure | No lymphadenectomy is performed in patients of the control group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | time from randomization until death |
| Measure | Description | Time Frame |
|---|---|---|
| - Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes | Progression-free survival time is calculated from the date of surgery until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Wagner, MD, Prof | University Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinik Graz | Graz | 8036 | Austria | |||
| Universitaetskliniken LKH Innsbruck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30811909 | Derived | Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424. |
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| Lymphadenectomy (LNE) |
| Procedure |
Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions [24, ]. |
|
| Innsbruck |
| 6020 |
| Austria |
| AKH Wien | Vienna | 1090 | Austria |
| Klinikum Wels-Grieskirchen | Wels | 4600 | Austria |
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| Odd G1, gyn. por. klinika VFN | Prague | 12808 | Czechia |
| Ostalb Klinikum Aalen | Aalen | 73430 | Germany |
| Klinikum Ansbach | Ansbach | 91522 | Germany |
| Hochtaunus-Kliniken gGmbH | Bad Homburg | 61348 | Germany |
| SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus | Berlin | 10365 | Germany |
| Charite Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitaetsklinikum Bonn | Bonn | 53105 | Germany |
| Malteser Krankenhaus Bonn-Rhein/Sieg | Bonn | 53123 | Germany |
| Klinikum Bremen | Bremen | 28177 | Germany |
| Universitaetsklinik Koeln | Cologne | 50931 | Germany |
| Klinikum des Landkreises Deggendorf | Deggendorf | 94469 | Germany |
| Donau-Ries Klinik Donauwoerth | Donauwörth | 86609 | Germany |
| Universitaetsklinikum Carl Gustac Carus | Dresden | 01304 | Germany |
| Evangelisches Krankenhaus | Düsseldorf | 40217 | Germany |
| Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus | Düsseldorf | 40489 | Germany |
| Universitaetsklinikum Erlangen-Nuernberg | Erlangen | 91054 | Germany |
| Universitaetsklinikum Essen | Essen | 45122 | Germany |
| Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH | Essen | 45136 | Germany |
| Klinikum der Johann-Wolfgang-Goethe Universitaet | Frankfurt | 60590 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Klinikum Fuerth | Fürth | 90766 | Germany |
| Klinikum Goettingen | Göttingen | 37075 | Germany |
| Klinikum der Ernst-Moritz-Arndt-Universitaet | Greifswald | 17485 | Germany |
| Universitaetsklikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Albertinen Krankenhaus | Hamburg | 22457 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitaetsklinikum Jena | Jena | 07743 | Germany |
| Universitaetsklinikum Schleswig Holstein, Campus Kiel | Kiel | 54105 | Germany |
| Asklepios Klinik | Lich | 35423 | Germany |
| Klinikum Lueneburg | Lüneburg | 21339 | Germany |
| Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie | Marburg | 35033 | Germany |
| Klinikum der Universität Muenchen-Grosshadern | München | 81377 | Germany |
| Klinikum rechts der Isar | München | 81675 | Germany |
| Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt | Neumarkt I. D. Opf | 92318 | Germany |
| Klinikum Offenbach | Offenbach | 63069 | Germany |
| Ortenau Klinikum St. Josefsklinik | Offenburg | 77654 | Germany |
| Oberschwabenklinik Krankenhaus St. Elisabeth | Ravensburg | 88212 | Germany |
| Caritas-Krankenhaus St. Josef | Regensburg | 93053 | Germany |
| Frauenklinik Sana-Klinikum Remscheid GmbH | Remscheid | 42859 | Germany |
| Staedtisches Klinikum Solingen | Solingen | 42653 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89075 | Germany |
| Dr. Horst-Schmidt-Klinik | Wiesbaden | 65199 | Germany |
| Klinikum der Stadt Wolfsburg | Wolfsburg | 38440 | Germany |
| Centro di Riferimento Oncologico | Aviano | 33081 | Italy |
| Università Cattolica del Sacro Cuore | Campobasso | 86100 | Italy |
| Ospedale di Carpi | Carpi | 41012 | Italy |
| Fondazione IRCCS | Milan | 20133 | Italy |
| IEO - European Institue of Oncology (Instituto Europeo di Oncologia) | Milan | 20141 | Italy |
| Azienda Ospedaliera S. Gerardo di Monza | Monza | 20052 | Italy |
| National Cancer Institute Naples | Naples | 80131 | Italy |
| Università Cattolica del Sacro Cuore | Rome | 00168 | Italy |
| Ospedale Mauriziano Torino | Torino | 10128 | Italy |
| Seoul National University Hospital | Seoul | 110-74 | South Korea |
| 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 |
|---|---|
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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