Actively Recruiting
Endometrial Cancer Lymphadenectomy Trial
Led by Philipps University Marburg · Updated on 2024-11-25
640
Participants Needed
61
Research Sites
568 weeks
Total Duration
On this page
Sponsors
P
Philipps University Marburg
Lead Sponsor
G
German Cancer Aid
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endometrial Cancer Lymphadenectomy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed endometrial cancer of clinical stages T1b and T2 (all histological types) or stage T1a G3 type 1 or type 2 tumors or carcinosarcoma
- No previous surgery for endometrial cancer or secondary surgery allowed within 8 weeks after hysterectomy if no lymphadenectomy was done
- Absence of bulky lymph nodes
- Performance status ECOG 0-1
- Age between 18 and 75 years
- Written informed consent provided
- Adequate compliance with study requirements
You will not qualify if you...
- Stage pT1a, G1 or G2 tumors of type 1 histology
- Sarcomas except carcinosarcoma
- Endometrial cancer of FIGO stages III or IV (except microscopic lymph node metastases)
- Evidence of extrauterine disease by visual inspection
- Recurrent endometrial cancer
- Previous chemo-, radio-, or endocrine therapy for endometrial cancer
- Any disease preventing surgery including lymphadenectomy or chemotherapy
- Medical history indicating high peri-operative risk
- Use of medications with significant surgical risk (e.g., oral anticoagulants)
- Conditions making trial participation or follow-up unlikely
- Presence of second malignancies that may affect prognosis
- Known HIV infection or AIDS
- Participation in other clinical trials not permitted by the steering committee
AI-Screening
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Trial Site Locations
Total: 61 locations
1
Ostalb-Klinikum Aalen, Frauenklinik
Aalen, Germany, 73430
Actively Recruiting
2
Klinikum St. Marien Amberg, Frauenklinik
Amberg, Germany, 92224
Actively Recruiting
3
Klinikum Ansbach, Klinikum Ansbach
Ansbach, Germany, 91522
Actively Recruiting
4
Universitätsklinikum Augsburg, Frauenklinik
Augsburg, Germany, 86156
Actively Recruiting
5
Hochtaunus-Kliniken gGmbH, Frauenklinik
Bad Homburg, Germany, 61325
Actively Recruiting
6
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
Bamberg, Germany, 96049
Actively Recruiting
7
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
Berlin, Germany, 10365
Actively Recruiting
8
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, Germany, 12157
Actively Recruiting
9
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
Berlin, Germany, 13353
Actively Recruiting
10
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, Germany, 13509
Actively Recruiting
11
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
Berlin, Germany, 14193
Actively Recruiting
12
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
Bonn, Germany, 53105
Actively Recruiting
13
Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
Borna, Germany, 04552
Actively Recruiting
14
Kliniken Böblingen, Frauenklinik
Böblingen, Germany, 71032
Actively Recruiting
15
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
Braunschweig, Germany, 38114
Actively Recruiting
16
Klinikum Bremen Mitte gGmbH, Frauenklinik
Bremen, Germany, 28177
Actively Recruiting
17
Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
Cologne, Germany, 51103
Actively Recruiting
18
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
Donauwörth, Germany, 86609
Active, Not Recruiting
19
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
Dresden, Germany, 01304
Actively Recruiting
20
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
Düsseldorf, Germany, 40489
Actively Recruiting
21
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
Essen, Germany, 45136
Actively Recruiting
22
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, Germany, 60590
Actively Recruiting
23
Universitätsklinikum Freiburg, Universitätsfrauenklinik
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
24
Klinikum Fulda gAG, Frauenklinik
Fulda, Germany, 36043
Actively Recruiting
25
Klinikum Fürth, Frauenklinik Nathanstift
Fürth, Germany, 90766
Actively Recruiting
26
Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
Giessen, Germany, 35392
Actively Recruiting
27
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
Göttingen, Germany, 37075
Actively Recruiting
28
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
Greifswald, Germany, 17475
Active, Not Recruiting
29
Klinikum Gütersloh, Frauenklinik
Gütersloh, Germany, 33332
Actively Recruiting
30
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
Halle, Germany, 06120
Actively Recruiting
31
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
Hamburg, Germany, 20246
Actively Recruiting
32
Agaplesion Diakonieklinikum Hamburg, Frauenklinik
Hamburg, Germany, 20259
Actively Recruiting
33
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
Hamburg, Germany, 22457
Actively Recruiting
34
Medizinische Hochschule Hannover, Frauenklinik
Hanover, Germany, 30625
Actively Recruiting
35
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
Jena, Germany, 07747
Actively Recruiting
36
Städtisches Klinikum Karlsruhe, Frauenklinik
Karlsruhe, Germany, 73133
Actively Recruiting
37
ViDia Christliche Kliniken Karlsruhe, Frauenklinik
Karlsruhe, Germany, 76135
Actively Recruiting
38
Klinikum Mannheim GmbH, Universitäts-Frauenklinik
Mannheim, Germany, 68167
Actively Recruiting
39
Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
Mönchengladbach, Germany, 41061
Actively Recruiting
40
Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
München, Germany, 80638
Actively Recruiting
41
Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
München, Germany, 81377
Actively Recruiting
42
Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
München, Germany, 81675
Actively Recruiting
43
Klinikum Offenbach GmbH, Frauenklinik
Offenbach, Germany, 63069
Actively Recruiting
44
Ortenau Klinikum St. Josefsklinik, Gynäkologie
Offenburg, Germany, 77654
Actively Recruiting
45
Klinikum Passau, Frauenklinik
Passau, Germany, 94032
Actively Recruiting
46
Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
Ravensburg, Germany, 88212
Actively Recruiting
47
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
Regensburg, Germany, 93053
Actively Recruiting
48
Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
Schweinfurt, Germany, 97422
Actively Recruiting
49
Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
Solingen, Germany, 42653
Actively Recruiting
50
Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
Starnberg, Germany, 82319
Actively Recruiting
51
Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
Straubing, Germany, 94315
Actively Recruiting
52
Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
Traunstein, Germany, 83278
Actively Recruiting
53
Universitätsklinikum Tübingen, Universitätsfrauenklinik
Tübingen, Germany, 72076
Actively Recruiting
54
Universitätsklinikum Ulm, Universitätsfrauenklinik
Ulm, Germany, 89075
Actively Recruiting
55
Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
Unna, Germany, 59423
Actively Recruiting
56
Schwarzwald-Baar Klinikum, Frauenklinik
Villingen-Schwenningen, Germany, 78052
Actively Recruiting
57
St. Josefs-Hospital, Frauenklinik
Wiesbaden, Germany, 65189
Actively Recruiting
58
Klinikum der Stadt Wolfsburg, Frauenklinik
Wolfsburg, Germany, 38440
Actively Recruiting
59
Okayama University Hospital
Okayama, Japan
Actively Recruiting
60
Saitama Medical University International Medical Center
Saitama, Japan
Actively Recruiting
61
Seoul National University Hospital, Department of Obstetrics & Gynecology
Seoul, South Korea, 110-744
Actively Recruiting
Research Team
P
Philipp Harter, Professor MD
CONTACT
G
Günter Emons, Professor MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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