Endometrial Cancer Lymphadenectomy Trial
ECLAT
Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
1 other identifier
interventional
640
3 countries
61
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
March 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2029
November 25, 2024
November 1, 2024
9.9 years
January 31, 2018
November 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Disease free survival (DFS)
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)
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
during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
EORTC QLQ-C30
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
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
- +1 more secondary outcomes
Study Arms (2)
Arm A standard surgical procedure
ACTIVE COMPARATORStandard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
Arm B systematic lymphadenectomy (LNE)
EXPERIMENTALIn addition to standard procedures as defined for Arm A: systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Interventions
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Eligibility Criteria
You may qualify if:
- histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation, mucinous) or type 2 tumors (any percentage of serous or clear cell component) or carcinosarcoma
- a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery)
- absence of bulky lymph nodes
- performance status ECOG 0-1
- age 18 - 75 years
- written informed consent
- adequate compliance
You may not qualify if:
- stage pT1a, G1 or G2 tumors of type 1 histology
- sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
- EC of FIGO stages III or IV (except for microscopical lymph node metastases)
- evidence of extrauterine disease by visual inspection
- recurrent EC
- preceding chemo-, radio, or endocrine therapy for EC
- any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
- any medical history indicating excessive peri-operative risk
- any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
- any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
- patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
- known HIV-infection or AIDS
- simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives of ECLAT are allowed)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philipps University Marburglead
- German Cancer Aidcollaborator
Study Sites (61)
Ostalb-Klinikum Aalen, Frauenklinik
Aalen, 73430, Germany
Klinikum St. Marien Amberg, Frauenklinik
Amberg, 92224, Germany
Klinikum Ansbach, Klinikum Ansbach
Ansbach, 91522, Germany
Universitätsklinikum Augsburg, Frauenklinik
Augsburg, 86156, Germany
Hochtaunus-Kliniken gGmbH, Frauenklinik
Bad Homburg, 61325, Germany
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
Bamberg, 96049, Germany
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
Berlin, 10365, Germany
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, 12157, Germany
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
Berlin, 13353, Germany
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, 13509, Germany
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
Berlin, 14193, Germany
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
Bonn, 53105, Germany
Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
Borna, 04552, Germany
Kliniken Böblingen, Frauenklinik
Böblingen, 71032, Germany
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
Braunschweig, 38114, Germany
Klinikum Bremen Mitte gGmbH, Frauenklinik
Bremen, 28177, Germany
Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
Cologne, 51103, Germany
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
Donauwörth, 86609, Germany
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
Dresden, 01304, Germany
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
Düsseldorf, 40489, Germany
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
Essen, 45136, Germany
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, 60590, Germany
Universitätsklinikum Freiburg, Universitätsfrauenklinik
Freiburg im Breisgau, 79106, Germany
Klinikum Fulda gAG, Frauenklinik
Fulda, 36043, Germany
Klinikum Fürth, Frauenklinik Nathanstift
Fürth, 90766, Germany
Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
Giessen, 35392, Germany
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
Göttingen, 37075, Germany
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
Greifswald, 17475, Germany
Klinikum Gütersloh, Frauenklinik
Gütersloh, 33332, Germany
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
Hamburg, 20246, Germany
Agaplesion Diakonieklinikum Hamburg, Frauenklinik
Hamburg, 20259, Germany
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
Hamburg, 22457, Germany
Medizinische Hochschule Hannover, Frauenklinik
Hanover, 30625, Germany
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
Jena, 07747, Germany
Städtisches Klinikum Karlsruhe, Frauenklinik
Karlsruhe, 73133, Germany
ViDia Christliche Kliniken Karlsruhe, Frauenklinik
Karlsruhe, 76135, Germany
Klinikum Mannheim GmbH, Universitäts-Frauenklinik
Mannheim, 68167, Germany
Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
Mönchengladbach, 41061, Germany
Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
München, 80638, Germany
Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
München, 81377, Germany
Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
München, 81675, Germany
Klinikum Offenbach GmbH, Frauenklinik
Offenbach, 63069, Germany
Ortenau Klinikum St. Josefsklinik, Gynäkologie
Offenburg, 77654, Germany
Klinikum Passau, Frauenklinik
Passau, 94032, Germany
Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
Ravensburg, 88212, Germany
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
Regensburg, 93053, Germany
Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
Schweinfurt, 97422, Germany
Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
Solingen, 42653, Germany
Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
Starnberg, 82319, Germany
Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
Straubing, 94315, Germany
Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
Traunstein, 83278, Germany
Universitätsklinikum Tübingen, Universitätsfrauenklinik
Tübingen, 72076, Germany
Universitätsklinikum Ulm, Universitätsfrauenklinik
Ulm, 89075, Germany
Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
Unna, 59423, Germany
Schwarzwald-Baar Klinikum, Frauenklinik
Villingen-Schwenningen, 78052, Germany
St. Josefs-Hospital, Frauenklinik
Wiesbaden, 65189, Germany
Klinikum der Stadt Wolfsburg, Frauenklinik
Wolfsburg, 38440, Germany
Okayama University Hospital
Okayama, Japan
Saitama Medical University International Medical Center
Saitama, Japan
Seoul National University Hospital, Department of Obstetrics & Gynecology
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 34226291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Harter, Professor MD
Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2018
First Posted
February 19, 2018
Study Start
March 28, 2018
Primary Completion (Estimated)
February 15, 2028
Study Completion (Estimated)
February 15, 2029
Last Updated
November 25, 2024
Record last verified: 2024-11