Cancer of Endometrium Stage IECLATNCT03438474
Endometrial Cancer Lymphadenectomy Trial
A study testing Standard surgical procedure for endometrial cancer and systematic lymphadenectomy (LNE) in people with Cancer of Endometrium Stage I and Cancer of Endometrium Stage II, run by Philipps University Marburg at 61 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cancer of Endometrium Stage I, Cancer of Endometrium Stage II
- What is being tested?
- Standard surgical procedure for endometrial cancer and systematic lymphadenectomy (LNE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 61 sitesin 3 countries
- Study dates
- 28 Mar 2018to 15 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
61 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 3 countries
Germany58 sites, 56 recruiting
- Recruiting
Ostalb-Klinikum Aalen, Frauenklinik
Aalen, 73430
Karsten Gnauert, MD, 0049 (0) 7361-551401, karsten.gnauert@kliniken-ostalb.de
- Recruiting
Klinikum St. Marien Amberg, Frauenklinik
Amberg, 92224
Thomas Papathemelis, MD, 0049 (0) 9621-381381, papathemelis.thomas@klinikum-amberg.de
- Recruiting
Klinikum Ansbach, Klinikum Ansbach
Ansbach, 91522
Martin Koch, MD, 0049 (0) 981-484 2256, martin.koch@anregiomed.de
- Recruiting
Universitätsklinikum Augsburg, Frauenklinik
Augsburg, 86156
Christian Dannecker, Professor MD, 0049 (0) 821-400-2331, christian.dannecker@med.uni-augsburg.de
- Recruiting
Hochtaunus-Kliniken gGmbH, Frauenklinik
Bad Homburg, 61325
Dominik Denschlag, Professor MD, 0049 (0) 6172 142 580, dominik.denschlag@hochtaunus-kliniken.de
- Recruiting
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
Bamberg, 96049
Hans-Martin Enzinger, MD, 0049 (0) 951-503 15730, hans-martin.enzinger@sozialstiftung-bamberg.de
- Recruiting
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
Berlin, 10365
Jens-Peter Scharf, MD, 0049 (0) 30-55182411, j.scharf@sana-kl.de
- Recruiting
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, 12157
Mandy Mangler, MD, 0049 (0) 30-130202402, mandy.mangler@vivantes.de
- Recruiting
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
Berlin, 13353
Mustafa Zelal Muallem, MD, 0049 (0) 30-450 664373, mustafa-zelal.muallem@charite.de
- Recruiting
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, 13509
Zaher Halwani, MD, 0049 (0) 30-130121261, zaher.halwani@vivantes.de
- Recruiting
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
Berlin, 14193
Uwe Ulrich, Professor MD, 0049 (0) 30-8955 83311, u.ulrich@mlk-berlin.de
- Recruiting
Kliniken Böblingen, Frauenklinik
Böblingen, 71032
Stefan Renner, Professor MD, 0049 (0) 7031-668-22201, S.Renner@klinikverbund-suedwest.de
- Recruiting
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
Bonn, 53105
Eva Egger, MD, 0049 (0) 228-287 15447, eva-katharina.egger@ukb.uni-bonn.de
- Recruiting
Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
Borna, 04552
Jens Einenkel, MD, 0049 (0) 3433 21-1400, jens.einenkel@sana.de
- Recruiting
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
Braunschweig, 38114
Heiko Franz, MD, 0049 (0) 531-595 3260, h.franz@klinikum-braunschweig.de
- Recruiting
Klinikum Bremen Mitte gGmbH, Frauenklinik
Bremen, 28177
Mustafa Aydogdu, MD, 0049 (0) 421-497 5351, mustafa.aydogdu@klinikum-bremen-mitte.de
- Recruiting
Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
Cologne, 51103
Dirk Michael Forner, MD, 0049 (0) 221-8289-5485, dirk.forner@evkk.de
- Active, not recruiting
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
Donauwörth, 86609
- Recruiting
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
Dresden, 01304
Pauline Wimberger, Professor MD, 0049 (0) 351-458 16728, pauline.wimberger@uniklinikum-dresden.de
- Recruiting
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
Düsseldorf, 40489
Björn Lampe, Professor MD, 0049 (0) 211-409 2519, lampe@kaiserswerther-diakonie.de
- Recruiting
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
Essen, 45136
Philipp Harter, MD, 0049 (0) 201-1743-4511, p.harter@kliniken-essen-mitte.de
- Recruiting
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, 60590
Ahmed El-Balat, MD, 0049 (0) 69 6301 7438, ahmed.el-balat@kgu.de
- Recruiting
Universitätsklinikum Freiburg, Universitätsfrauenklinik
Freiburg im Breisgau, 79106
Maximilian Klar, MD, 0049 (0) 761-270 30010, maximilian.klar@uniklinik-freiburg.de
- Recruiting
Klinikum Fulda gAG, Frauenklinik
Fulda, 36043
Thomas Hawighorst, MD, 0049 (0) 661-84 5901, Thomas.Hawighorst@klinikum-fulda.de
- Recruiting
Klinikum Fürth, Frauenklinik Nathanstift
Fürth, 90766
Volker Hanf, Professor MD, 0049 (0) 911-7580 1301, volker.hanf@klinikum-fuerth.de
- Recruiting
Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
Giessen, 35392
Ivo Meinhold-Heerlein, Professor MD, 0049 (0) 641-985-45100, ivo.meinhold-heerlein@gyn.med.uni-giessen.de
- Recruiting
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
Göttingen, 37075
Gerd Bauerschmitz, MD, 0049 (0) 551-39 66582, gerd.bauerschmitz@med.uni-goettingen.de
- Active, not recruiting
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
Greifswald, 17475
- Recruiting
Klinikum Gütersloh, Frauenklinik
Gütersloh, 33332
Wencke Ruhwedel, MD, 0049 (0) 5241-832-4102, wencke.ruhwedel@klinikum-guetersloh.de
- Recruiting
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
Halle, 06120
Nancy Papendick, MD, 0049 (0) 345-557 1323, nancy.papendick@uk-halle.de
- Recruiting
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
Hamburg, 20246
Barbara Schmalfeldt, Professor MD, 0049 (0) 40-7410 52510, b.schmalfeldt@uke.de
- Recruiting
Agaplesion Diakonieklinikum Hamburg, Frauenklinik
Hamburg, 20259
Christoph Lindner, Professor MD, 0049 (0) 40-790 20 2500, christoph.lindner@d-k-h.de
- Recruiting
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
Hamburg, 22457
Uwe Herwig, MD, 0049 (0) 40-5588-6752, uwe.herwig@albertinen.de
- Recruiting
Medizinische Hochschule Hannover, Frauenklinik
Hanover, 30625
Peter Hillemanns, Professor MD, 0049 (0) 511-532 6144, hillemanns.peter@mh-hannover.de
- Recruiting
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
Jena, 07747
Ingo B. Runnebaum, Professor MD, 0049 (0) 3641-933063, ingo.runnebaum@med.uni-jena.de
- Recruiting
Städtisches Klinikum Karlsruhe, Frauenklinik
Karlsruhe, 73133
Andreas Müller, Professor MD, 0049 (0) 721-974 2401, andreas.mueller.fk@klinikum-karlsruhe.de
- Recruiting
ViDia Christliche Kliniken Karlsruhe, Frauenklinik
Karlsruhe, 76135
Oliver Tomé, MD, 0049 (0) 721-8108 9003, oliver.tome@vincentius-ka.de
- Recruiting
Klinikum Mannheim GmbH, Universitäts-Frauenklinik
Mannheim, 68167
Benjamin Tuschy, Professor MD, 0049 (0) 621-383-4176, benjamin.tuschy@umm.de
- Recruiting
Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
Mönchengladbach, 41061
Darius Salehin, MD, 0049 (0) 2161-981 1105, darius.salehin@mg.johanniter-kliniken.de
- Recruiting
Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
München, 80638
Franz Edler von Koch, MD, 0049 (0)89-17952501, franz.koch@dritter-orden.de
- Recruiting
Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
München, 81377
Fabian Trillsch, MD, 0049 (0) 89-4400-73723, Fabian.Trillsch@med.uni-muenchen.de
- Recruiting
Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
München, 81675
Holger Bronger, MD, 0049 (0) 89-4140 2433, holger.bronger@mri.tum.de
- Recruiting
Klinikum Offenbach GmbH, Frauenklinik
Offenbach, 63069
Jens Kosse, MD, 0049 (0) 69-8405 7312, jens.kosse@sana.de
- Recruiting
Ortenau Klinikum St. Josefsklinik, Gynäkologie
Offenburg, 77654
Matthias Frank, 0049 (0) 781-472 3503, matthias.frank@og.ortenau-klinikum.de
- Recruiting
Klinikum Passau, Frauenklinik
Passau, 94032
Martin Dengler, MD, 0049 (0) 851-5300 2297, martin.dengler@klinikum-passau.de
- Recruiting
Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
Ravensburg, 88212
Martina Gropp-Meier, MD, 0049 (0) 751-87 2447, martina.gropp-meier@oberschwabenklinik.de
- Recruiting
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
Regensburg, 93053
Stephan Seitz, MD, 0049 (0) 941-782 3403, sseitz@caritasstjosef.de
- Recruiting
Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
Schweinfurt, 97422
Michael Weigel, Professor MD, 0049 (0) 9721-720 2132, mweigel@leopoldina.de
- Recruiting
Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
Solingen, 42653
Sebastian Hentsch, MD, 0049 (0) 212-547 2371, hentsch@klinikumsolingen.de
- Recruiting
Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
Starnberg, 82319
Christoph Anthuber, Professor MD, 0049 (0) 8151-18 2312, christoph.anthuber@klinikum-starnberg.de
- Recruiting
Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
Straubing, 94315
Carsten Scholz, MD, 0049 (0) 9421-710 1450, Carsten.Scholz@klinikum-straubing.de
- Recruiting
Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
Traunstein, 83278
Christian Schindlbeck, MD, 0049 (0) 861-705 1231, christian.schindlbeck@kliniken-sob.de
- Recruiting
Universitätsklinikum Tübingen, Universitätsfrauenklinik
Tübingen, 72076
Stefan Kommoss, Professor MD, 0049 (0) 7071-29 82211, stefan.kommoss@med.uni-tuebingen.de
- Recruiting
Universitätsklinikum Ulm, Universitätsfrauenklinik
Ulm, 89075
Fabienne Schochter, MD, 0049 (0) 731-500 58688, fabienne.schochter@uniklinik-ulm.de
- Recruiting
Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
Unna, 59423
Cristin Kühn, MD, 0049 (0) 2303-100 2071, c.kuehn@hospitalverbund.de
- Recruiting
Schwarzwald-Baar Klinikum, Frauenklinik
Villingen-Schwenningen, 78052
Kurt Seeborg, 0049 (0) 7721-933116, kurt.seeborg@sbk-vs.de
- Recruiting
St. Josefs-Hospital, Frauenklinik
Wiesbaden, 65189
Boris Gabriel, Professor MD, 0049 (0) 611-177 1512, bgabriel@joho.de
- Recruiting
Klinikum der Stadt Wolfsburg, Frauenklinik
Wolfsburg, 38440
Clemens Liebrich, MD, 0049 (0) 5361-80 3813, clemens.liebrich@klinikum.wolfsburg.de
Japan2 sites, 2 recruiting
- Recruiting
Okayama University Hospital
Okayama
Shoji Nagao, MD
- Recruiting
Saitama Medical University International Medical Center
Saitama
Yabuno Akira, MD
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital, Department of Obstetrics & Gynecology
Seoul, 110-744
Jae Weon Kim, Professor MD, 0082-2-2072-2821, kjwksh@snu.ac.kr
About this study
Official title: Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
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.
- Being tested
- Standard surgical procedure for endometrial cancer, systematic lymphadenectomy (LNE)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard surgical procedure for endometrial cancerProcedure or surgery
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
systematic lymphadenectomy (LNE)Procedure or surgery
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
| Study group | Role | What they receive |
|---|---|---|
| Arm A standard surgical procedure | Active comparator | Standard surgical procedure for endometrial cancer:
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers) Receives: Procedure: Standard surgical procedure for endometrial cancer |
| 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 Receives: Procedure: Standard surgical procedure for endometrial cancer; Procedure: systematic lymphadenectomy (LNE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
Measured: 60 months
Secondary outcomes (6)
Disease free survival (DFS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival
Measured: 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)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival
Measured: 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
Measured: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
EORTC QLQ-C30
Health related Quality of life (QoL)
Measured: 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)
Measured: 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
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Mar 2018
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of Endometrium Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Sponsor
- Investigators
- Philipp Harter, Professor MD, Principal investigator, Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438474
- Sponsor's protocol ID
- AGO-OP.6 KKS 228
- Acronym
- ECLAT
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2018
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38286085Emons 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.
PubMed 34226291
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT03438474
- Acronym / sponsor ID
- ECLAT / AGO-OP.6 KKS 228
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A standard surgical procedure | Active comparator | Procedure: Standard surgical procedure for endometrial cancerStandard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers) |
| Arm B systematic lymphadenectomy (LNE) | Experimental | Procedure: Standard surgical procedure for endometrial cancer, Procedure: systematic lymphadenectomy (LNE)In addition to standard procedures as defined for Arm A: systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard surgical procedure for endometrial cancertotal hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers) | Procedure or surgery | Arm A standard surgical procedure, Arm B systematic lymphadenectomy (LNE) |
| systematic lymphadenectomy (LNE)systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels | Procedure or surgery | Arm B systematic lymphadenectomy (LNE) |
Primary outcome
Overall survival (OS)
Time frame: 60 months
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
6 secondary outcomes
Disease free survival (DFS)
Time frame: 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)
Time frame: 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
Time frame: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
EORTC QLQ-C30
Time frame: 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
Time frame: 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
Time frame: during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 38286085Leone 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.
- Derived from this study: PubMed 34226291Emons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Harter, Professor MD principal investigator
Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie
61 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard surgical procedure for endometrial cancer and systematic lymphadenectomy (LNE) in people with Cancer of Endometrium Stage I and Cancer of Endometrium Stage II, run by Philipps University Marburg at 61 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Germany, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Harter, Professor MD (+49 (0) 201 174-34511, p.harter@kem-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.