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Endometrial Cancer Lymphadenectomy Trial

NCT ID: NCT03438474

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2029-02-15

Brief Summary

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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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Detailed Description

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Conditions

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Cancer of Endometrium Stage I Cancer of Endometrium Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A standard surgical procedure

Standard surgical procedure for endometrial cancer:

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

Group Type ACTIVE_COMPARATOR

Standard surgical procedure for endometrial cancer

Intervention Type PROCEDURE

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

Arm B 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

Group Type EXPERIMENTAL

Standard surgical procedure for endometrial cancer

Intervention Type PROCEDURE

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

systematic lymphadenectomy (LNE)

Intervention Type PROCEDURE

systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels

Interventions

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Standard surgical procedure for endometrial cancer

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

Intervention Type PROCEDURE

systematic lymphadenectomy (LNE)

systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 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
2. 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)
3. absence of bulky lymph nodes
4. performance status ECOG 0-1
5. age 18 - 75 years
6. written informed consent
7. adequate compliance

Exclusion Criteria

1. stage pT1a, G1 or G2 tumors of type 1 histology
2. sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
3. EC of FIGO stages III or IV (except for microscopical lymph node metastases)
4. evidence of extrauterine disease by visual inspection
5. recurrent EC
6. preceding chemo-, radio, or endocrine therapy for EC
7. any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
8. any medical history indicating excessive peri-operative risk
9. any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
10. any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
11. patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
12. known HIV-infection or AIDS
13. 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Aid

OTHER

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp Harter, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie

Locations

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Ostalb-Klinikum Aalen, Frauenklinik

Aalen, , Germany

Site Status RECRUITING

Klinikum St. Marien Amberg, Frauenklinik

Amberg, , Germany

Site Status RECRUITING

Klinikum Ansbach, Klinikum Ansbach

Ansbach, , Germany

Site Status RECRUITING

Universitätsklinikum Augsburg, Frauenklinik

Augsburg, , Germany

Site Status RECRUITING

Hochtaunus-Kliniken gGmbH, Frauenklinik

Bad Homburg, , Germany

Site Status RECRUITING

Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde

Bamberg, , Germany

Site Status RECRUITING

SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik

Berlin, , Germany

Site Status RECRUITING

Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin

Berlin, , Germany

Site Status RECRUITING

Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe

Berlin, , Germany

Site Status RECRUITING

Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin

Berlin, , Germany

Site Status RECRUITING

Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe

Berlin, , Germany

Site Status RECRUITING

Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde

Bonn, , Germany

Site Status RECRUITING

Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe

Borna, , Germany

Site Status RECRUITING

Kliniken Böblingen, Frauenklinik

Böblingen, , Germany

Site Status RECRUITING

Städtisches Klinikum Braunschweig gGmbH, Frauenklinik

Braunschweig, , Germany

Site Status RECRUITING

Klinikum Bremen Mitte gGmbH, Frauenklinik

Bremen, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe

Cologne, , Germany

Site Status RECRUITING

Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe

Donauwörth, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe

Dresden, , Germany

Site Status RECRUITING

Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe

Düsseldorf, , Germany

Site Status RECRUITING

Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie

Essen, , Germany

Site Status RECRUITING

Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg, Universitätsfrauenklinik

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Klinikum Fulda gAG, Frauenklinik

Fulda, , Germany

Site Status RECRUITING

Klinikum Fürth, Frauenklinik Nathanstift

Fürth, , Germany

Site Status RECRUITING

Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik

Giessen, , Germany

Site Status RECRUITING

Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik

Göttingen, , Germany

Site Status RECRUITING

Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe

Greifswald, , Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum Gütersloh, Frauenklinik

Gütersloh, , Germany

Site Status RECRUITING

Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie

Halle, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie

Hamburg, , Germany

Site Status RECRUITING

Agaplesion Diakonieklinikum Hamburg, Frauenklinik

Hamburg, , Germany

Site Status RECRUITING

Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie

Hamburg, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover, Frauenklinik

Hanover, , Germany

Site Status RECRUITING

Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe

Jena, , Germany

Site Status RECRUITING

Städtisches Klinikum Karlsruhe, Frauenklinik

Karlsruhe, , Germany

Site Status RECRUITING

ViDia Christliche Kliniken Karlsruhe, Frauenklinik

Karlsruhe, , Germany

Site Status RECRUITING

Klinikum Mannheim GmbH, Universitäts-Frauenklinik

Mannheim, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe

Mönchengladbach, , Germany

Site Status RECRUITING

Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe

München, , Germany

Site Status RECRUITING

Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

München, , Germany

Site Status RECRUITING

Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik

München, , Germany

Site Status RECRUITING

Klinikum Offenbach GmbH, Frauenklinik

Offenbach, , Germany

Site Status RECRUITING

Ortenau Klinikum St. Josefsklinik, Gynäkologie

Offenburg, , Germany

Site Status RECRUITING

Klinikum Passau, Frauenklinik

Passau, , Germany

Site Status RECRUITING

Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik

Ravensburg, , Germany

Site Status RECRUITING

Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe

Regensburg, , Germany

Site Status RECRUITING

Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe

Schweinfurt, , Germany

Site Status RECRUITING

Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe

Solingen, , Germany

Site Status RECRUITING

Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe

Starnberg, , Germany

Site Status RECRUITING

Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe

Straubing, , Germany

Site Status RECRUITING

Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik

Traunstein, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen, Universitätsfrauenklinik

Tübingen, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm, Universitätsfrauenklinik

Ulm, , Germany

Site Status RECRUITING

Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe

Unna, , Germany

Site Status RECRUITING

Schwarzwald-Baar Klinikum, Frauenklinik

Villingen-Schwenningen, , Germany

Site Status RECRUITING

St. Josefs-Hospital, Frauenklinik

Wiesbaden, , Germany

Site Status RECRUITING

Klinikum der Stadt Wolfsburg, Frauenklinik

Wolfsburg, , Germany

Site Status RECRUITING

Okayama University Hospital

Okayama, , Japan

Site Status RECRUITING

Saitama Medical University International Medical Center

Saitama, , Japan

Site Status RECRUITING

Seoul National University Hospital, Department of Obstetrics & Gynecology

Seoul, , South Korea

Site Status RECRUITING

Countries

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Germany Japan South Korea

Central Contacts

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Philipp Harter, Professor MD

Role: CONTACT

[email protected]
+49 (0) 201 174-34511

Günter Emons, Professor MD

Role: CONTACT

[email protected]
+49 (0) 551-39 66501

Facility Contacts

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Karsten Gnauert, MD

Role: primary

[email protected]
0049 (0) 7361-551401

Thomas Papathemelis, MD

Role: primary

[email protected]
0049 (0) 9621-381381

Martin Koch, MD

Role: primary

[email protected]
0049 (0) 981-484 2256

Christian Dannecker, Professor MD

Role: primary

[email protected]
0049 (0) 821-400-2331

Dominik Denschlag, Professor MD

Role: primary

[email protected]
0049 (0) 6172 142 580

Hans-Martin Enzinger, MD

Role: primary

[email protected]
0049 (0) 951-503 15730

Jens-Peter Scharf, MD

Role: primary

[email protected]
0049 (0) 30-55182411

Mandy Mangler, MD

Role: primary

[email protected]
0049 (0) 30-130202402

Mustafa Zelal Muallem, MD

Role: primary

[email protected]
0049 (0) 30-450 664373

Zaher Halwani, MD

Role: primary

[email protected]
0049 (0) 30-130121261

Uwe Ulrich, Professor MD

Role: primary

[email protected]
0049 (0) 30-8955 83311

Eva Egger, MD

Role: primary

[email protected]
0049 (0) 228-287 15447

Jens Einenkel, MD

Role: primary

[email protected]
0049 (0) 3433 21-1400

Stefan Renner, Professor MD

Role: primary

[email protected]
0049 (0) 7031-668-22201

Heiko Franz, MD

Role: primary

[email protected]
0049 (0) 531-595 3260

Mustafa Aydogdu, MD

Role: primary

[email protected]
0049 (0) 421-497 5351

Dirk Michael Forner, MD

Role: primary

[email protected]
0049 (0) 221-8289-5485

Pauline Wimberger, Professor MD

Role: primary

[email protected]
0049 (0) 351-458 16728

Björn Lampe, Professor MD

Role: primary

[email protected]
0049 (0) 211-409 2519

Philipp Harter, MD

Role: primary

[email protected]
0049 (0) 201-1743-4511

Ahmed El-Balat, MD

Role: primary

[email protected]
0049 (0) 69 6301 7438

Maximilian Klar, MD

Role: primary

[email protected]
0049 (0) 761-270 30010

Thomas Hawighorst, MD

Role: primary

[email protected]
0049 (0) 661-84 5901

Volker Hanf, Professor MD

Role: primary

[email protected]
0049 (0) 911-7580 1301

Ivo Meinhold-Heerlein, Professor MD

Role: primary

[email protected]
0049 (0) 641-985-45100

Gerd Bauerschmitz, MD

Role: primary

[email protected]
0049 (0) 551-39 66582

Wencke Ruhwedel, MD

Role: primary

[email protected]
0049 (0) 5241-832-4102

Nancy Papendick, MD

Role: primary

[email protected]
0049 (0) 345-557 1323

Barbara Schmalfeldt, Professor MD

Role: primary

[email protected]
0049 (0) 40-7410 52510

Christoph Lindner, Professor MD

Role: primary

[email protected]
0049 (0) 40-790 20 2500

Uwe Herwig, MD

Role: primary

[email protected]
0049 (0) 40-5588-6752

Peter Hillemanns, Professor MD

Role: primary

[email protected]
0049 (0) 511-532 6144

Ingo B. Runnebaum, Professor MD

Role: primary

[email protected]
0049 (0) 3641-933063

Andreas Müller, Professor MD

Role: primary

[email protected]
0049 (0) 721-974 2401

Oliver Tomé, MD

Role: primary

[email protected]
0049 (0) 721-8108 9003

Benjamin Tuschy, Professor MD

Role: primary

[email protected]
0049 (0) 621-383-4176

Darius Salehin, MD

Role: primary

[email protected]
0049 (0) 2161-981 1105

Franz Edler von Koch, MD

Role: primary

[email protected]
0049 (0)89-17952501

Fabian Trillsch, MD

Role: primary

[email protected]
0049 (0) 89-4400-73723

Holger Bronger, MD

Role: primary

[email protected]
0049 (0) 89-4140 2433

Jens Kosse, MD

Role: primary

[email protected]
0049 (0) 69-8405 7312

Matthias Frank

Role: primary

[email protected]
0049 (0) 781-472 3503

Martin Dengler, MD

Role: primary

[email protected]
0049 (0) 851-5300 2297

Martina Gropp-Meier, MD

Role: primary

[email protected]
0049 (0) 751-87 2447

Stephan Seitz, MD

Role: primary

[email protected]
0049 (0) 941-782 3403

Michael Weigel, Professor MD

Role: primary

[email protected]
0049 (0) 9721-720 2132

Sebastian Hentsch, MD

Role: primary

[email protected]
0049 (0) 212-547 2371

Christoph Anthuber, Professor MD

Role: primary

[email protected]
0049 (0) 8151-18 2312

Carsten Scholz, MD

Role: primary

[email protected]
0049 (0) 9421-710 1450

Christian Schindlbeck, MD

Role: primary

[email protected]
0049 (0) 861-705 1231

Stefan Kommoss, Professor MD

Role: primary

[email protected]
0049 (0) 7071-29 82211

Fabienne Schochter, MD

Role: primary

[email protected]
0049 (0) 731-500 58688

Cristin Kühn, MD

Role: primary

[email protected]
0049 (0) 2303-100 2071

Kurt Seeborg

Role: primary

[email protected]
0049 (0) 7721-933116

Boris Gabriel, Professor MD

Role: primary

[email protected]
0049 (0) 611-177 1512

Clemens Liebrich, MD

Role: primary

[email protected]
0049 (0) 5361-80 3813

Shoji Nagao, MD

Role: primary

Yabuno Akira, MD

Role: primary

Jae Weon Kim, Professor MD

Role: primary

[email protected]
0082-2-2072-2821

References

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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.

Reference Type DERIVED
PMID: 34226291 (View on PubMed)

Other Identifiers

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AGO-OP.6 KKS 228

Identifier Type: -

Identifier Source: org_study_id

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