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| Name | Class |
|---|---|
| German Cancer Aid | OTHER |
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The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A standard surgical procedure | Active Comparator | Standard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers) |
|
| Arm B systematic lymphadenectomy (LNE) | Experimental | In addition to standard procedures as defined for Arm A: systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard surgical procedure for endometrial cancer | Procedure | total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival | 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months |
| Disease specific survival (DSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp Harter, Professor MD | Contact | +49 (0) 201 174-34511 | p.harter@kem-med.com | |
| Günter Emons, Professor MD | Contact | +49 (0) 551-39 66501 | emons@med.uni-goettingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Harter, Professor MD | Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ostalb-Klinikum Aalen, Frauenklinik | Recruiting | Aalen | 73430 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38286085 | Derived | Leone Roberti Maggiore U, Spano Bascio L, Alboni C, Chiarello G, Savelli L, Bogani G, Martinelli F, Chiappa V, Ditto A, Raspagliesi F. Sentinel lymph node biopsy in endometrial cancer: When, how and in which patients. Eur J Surg Oncol. 2024 Mar;50(3):107956. doi: 10.1016/j.ejso.2024.107956. Epub 2024 Jan 17. | |
| 34226291 | Derived |
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| systematic lymphadenectomy (LNE) | Procedure | systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels |
|
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival |
| 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months |
| Assessment of serious complications | Assessment of perioperative complications and site effects of LNE | during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months |
| EORTC QLQ-C30 | Health related Quality of life (QoL) | Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months |
| EORTC QLQ-EN24 | Health related Quality of life (QoL) | Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months |
| Number of resected lymph nodes | resected pelvic and para-aortic lymph nodes | during surgery |
| Klinikum St. Marien Amberg, Frauenklinik | Recruiting | Amberg | 92224 | Germany |
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| Klinikum Ansbach, Klinikum Ansbach | Recruiting | Ansbach | 91522 | Germany |
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| Universitätsklinikum Augsburg, Frauenklinik | Recruiting | Augsburg | 86156 | Germany |
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| Hochtaunus-Kliniken gGmbH, Frauenklinik | Recruiting | Bad Homburg | 61325 | Germany |
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| Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde | Recruiting | Bamberg | 96049 | Germany |
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| SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik | Recruiting | Berlin | 10365 | Germany |
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| Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin | Recruiting | Berlin | 12157 | Germany |
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| Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe | Recruiting | Berlin | 13353 | Germany |
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| Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin | Recruiting | Berlin | 13509 | Germany |
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| Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe | Recruiting | Berlin | 14193 | Germany |
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| Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde | Recruiting | Bonn | 53105 | Germany |
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| Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe | Recruiting | Borna | 04552 | Germany |
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| Kliniken Böblingen, Frauenklinik | Recruiting | Böblingen | 71032 | Germany |
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| Städtisches Klinikum Braunschweig gGmbH, Frauenklinik | Recruiting | Braunschweig | 38114 | Germany |
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| Klinikum Bremen Mitte gGmbH, Frauenklinik | Recruiting | Bremen | 28177 | Germany |
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| Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe | Recruiting | Cologne | 51103 | Germany |
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| Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe | Active, not recruiting | Donauwörth | 86609 | Germany |
| Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe | Recruiting | Dresden | 01304 | Germany |
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| Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe | Recruiting | Düsseldorf | 40489 | Germany |
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| Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie | Recruiting | Essen | 45136 | Germany |
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| Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe | Recruiting | Frankfurt am Main | 60590 | Germany |
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| Universitätsklinikum Freiburg, Universitätsfrauenklinik | Recruiting | Freiburg im Breisgau | 79106 | Germany |
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| Klinikum Fulda gAG, Frauenklinik | Recruiting | Fulda | 36043 | Germany |
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| Klinikum Fürth, Frauenklinik Nathanstift | Recruiting | Fürth | 90766 | Germany |
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| Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik | Recruiting | Giessen | 35392 | Germany |
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| Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik | Recruiting | Göttingen | 37075 | Germany |
|
| Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe | Active, not recruiting | Greifswald | 17475 | Germany |
| Klinikum Gütersloh, Frauenklinik | Recruiting | Gütersloh | 33332 | Germany |
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| Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie | Recruiting | Halle | 06120 | Germany |
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| Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie | Recruiting | Hamburg | 20246 | Germany |
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| Agaplesion Diakonieklinikum Hamburg, Frauenklinik | Recruiting | Hamburg | 20259 | Germany |
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| Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie | Recruiting | Hamburg | 22457 | Germany |
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| Medizinische Hochschule Hannover, Frauenklinik | Recruiting | Hanover | 30625 | Germany |
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| Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe | Recruiting | Jena | 07747 | Germany |
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| Städtisches Klinikum Karlsruhe, Frauenklinik | Recruiting | Karlsruhe | 73133 | Germany |
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| ViDia Christliche Kliniken Karlsruhe, Frauenklinik | Recruiting | Karlsruhe | 76135 | Germany |
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| Klinikum Mannheim GmbH, Universitäts-Frauenklinik | Recruiting | Mannheim | 68167 | Germany |
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| Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe | Recruiting | Mönchengladbach | 41061 | Germany |
|
| Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe | Recruiting | München | 80638 | Germany |
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| Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | Recruiting | München | 81377 | Germany |
|
| Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik | Recruiting | München | 81675 | Germany |
|
| Klinikum Offenbach GmbH, Frauenklinik | Recruiting | Offenbach | 63069 | Germany |
|
| Ortenau Klinikum St. Josefsklinik, Gynäkologie | Recruiting | Offenburg | 77654 | Germany |
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| Klinikum Passau, Frauenklinik | Recruiting | Passau | 94032 | Germany |
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| Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik | Recruiting | Ravensburg | 88212 | Germany |
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| Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe | Recruiting | Regensburg | 93053 | Germany |
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| Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe | Recruiting | Schweinfurt | 97422 | Germany |
|
| Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe | Recruiting | Solingen | 42653 | Germany |
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| Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe | Recruiting | Starnberg | 82319 | Germany |
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| Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe | Recruiting | Straubing | 94315 | Germany |
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| Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik | Recruiting | Traunstein | 83278 | Germany |
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| Universitätsklinikum Tübingen, Universitätsfrauenklinik | Recruiting | Tübingen | 72076 | Germany |
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| Universitätsklinikum Ulm, Universitätsfrauenklinik | Recruiting | Ulm | 89075 | Germany |
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| Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe | Recruiting | Unna | 59423 | Germany |
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| Schwarzwald-Baar Klinikum, Frauenklinik | Recruiting | Villingen-Schwenningen | 78052 | Germany |
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| St. Josefs-Hospital, Frauenklinik | Recruiting | Wiesbaden | 65189 | Germany |
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| Klinikum der Stadt Wolfsburg, Frauenklinik | Recruiting | Wolfsburg | 38440 | Germany |
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| Okayama University Hospital | Recruiting | Okayama | Japan |
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| Saitama Medical University International Medical Center | Recruiting | Saitama | Japan |
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| Seoul National University Hospital, Department of Obstetrics & Gynecology | Recruiting | Seoul | 110-744 | South Korea |
|
| Emons G, Kim JW, Weide K, de Gregorio N, Wimberger P, Trillsch F, Gabriel B, Denschlag D, Kommoss S, Aydogdu M, Papathemelis T, Gropp-Meier M, Muallem MZ, Kuhn C, Muller A, Frank M, Weigel M, Bronger H, Lampe B, Rau J, Schade-Brittinger C, Harter P. Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6). Int J Gynecol Cancer. 2021 Jul;31(7):1075-1079. doi: 10.1136/ijgc-2021-002703. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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