Endometrial Cancer Lymphadenectomy Trial

Last updated: November 22, 2024
Sponsor: Philipps University Marburg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometrial Cancer

Treatment

systematic lymphadenectomy (LNE)

Standard surgical procedure for endometrial cancer

Clinical Study ID

NCT03438474
AGO-OP.6 KKS 228
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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) orcarcinosarcoma

  2. a) no previous surgery concerning EC (primary surgery) or b) surgery afterhysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8weeks 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

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/orchemotherapy

  8. any medical history indicating excessive peri-operative risk

  9. any current medication containing considerable surgical risk (e.g. bleeding: due tooral anticoagulating agents)

  10. any known disorder or circumstances making participation in trial and follow-upquestionable. Insufficient compliance is expected.

  11. patients with second malignancies if disease or treatment might have an impact onthe patient's prognosis

  12. known HIV-infection or AIDS

  13. simultaneous participation in other clinical trials if not permitted by the steeringcommittee (translational or QoL studies not interfering with the objectives of ECLATare allowed)

Study Design

Total Participants: 640
Treatment Group(s): 2
Primary Treatment: systematic lymphadenectomy (LNE)
Phase:
Study Start date:
March 28, 2018
Estimated Completion Date:
February 15, 2029

Connect with a study center

  • Ostalb-Klinikum Aalen, Frauenklinik

    Aalen, 73430
    Germany

    Active - Recruiting

  • Klinikum St. Marien Amberg, Frauenklinik

    Amberg, 92224
    Germany

    Active - Recruiting

  • Klinikum Ansbach, Klinikum Ansbach

    Ansbach, 91522
    Germany

    Active - Recruiting

  • Universitätsklinikum Augsburg, Frauenklinik

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Hochtaunus-Kliniken gGmbH, Frauenklinik

    Bad Homburg, 61325
    Germany

    Active - Recruiting

  • Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde

    Bamberg, 96049
    Germany

    Active - Recruiting

  • Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe

    Berlin, 13353
    Germany

    Active - Recruiting

  • Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe

    Berlin, 14193
    Germany

    Active - Recruiting

  • SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik

    Berlin, 10365
    Germany

    Active - Recruiting

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

    Berlin, 12157
    Germany

    Active - Recruiting

  • Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin

    Berlin, 13509
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde

    Bonn, 53105
    Germany

    Active - Recruiting

  • Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe

    Borna, 04552
    Germany

    Active - Recruiting

  • Städtisches Klinikum Braunschweig gGmbH, Frauenklinik

    Braunschweig, 38114
    Germany

    Active - Recruiting

  • Klinikum Bremen Mitte gGmbH, Frauenklinik

    Bremen, 28177
    Germany

    Active - Recruiting

  • Kliniken Böblingen, Frauenklinik

    Böblingen, 71032
    Germany

    Active - Recruiting

  • Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe

    Donauwörth, 86609
    Germany

    Site Not Available

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

    Dresden, 01304
    Germany

    Active - Recruiting

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

    Düsseldorf, 40489
    Germany

    Active - Recruiting

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

    Essen, 45136
    Germany

    Active - Recruiting

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

    Frankfurt/Main, 60590
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg, Universitätsfrauenklinik

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Klinikum Fulda gAG, Frauenklinik

    Fulda, 36043
    Germany

    Active - Recruiting

  • Klinikum Fürth, Frauenklinik Nathanstift

    Fürth, 90766
    Germany

    Active - Recruiting

  • Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik

    Gießen, 35392
    Germany

    Active - Recruiting

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

    Greifswald, 17475
    Germany

    Site Not Available

  • Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Klinikum Gütersloh, Frauenklinik

    Gütersloh, 33332
    Germany

    Active - Recruiting

  • Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie

    Halle/Saale, 06120
    Germany

    Active - Recruiting

  • Agaplesion Diakonieklinikum Hamburg, Frauenklinik

    Hamburg, 20259
    Germany

    Active - Recruiting

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

    Hamburg, 22457
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover, Frauenklinik

    Hannover, 30625
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe

    Jena, 07747
    Germany

    Active - Recruiting

  • Städtisches Klinikum Karlsruhe, Frauenklinik

    Karlsruhe, 73133
    Germany

    Active - Recruiting

  • ViDia Christliche Kliniken Karlsruhe, Frauenklinik

    Karlsruhe, 76135
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe

    Köln, 51103
    Germany

    Active - Recruiting

  • Klinikum Mannheim GmbH, Universitäts-Frauenklinik

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe

    Mönchengladbach, 41061
    Germany

    Active - Recruiting

  • Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe

    München, 80638
    Germany

    Active - Recruiting

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

    München, 81377
    Germany

    Active - Recruiting

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

    München, 81675
    Germany

    Active - Recruiting

  • Klinikum Nürnberg Nord, Klinik für Frauenheilkunde

    Nürnberg, 90419
    Germany

    Site Not Available

  • Klinikum Offenbach GmbH, Frauenklinik

    Offenbach, 63069
    Germany

    Active - Recruiting

  • Ortenau Klinikum St. Josefsklinik, Gynäkologie

    Offenburg, 77654
    Germany

    Active - Recruiting

  • Klinikum Passau, Frauenklinik

    Passau, 94032
    Germany

    Active - Recruiting

  • Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik

    Ravensburg, 88212
    Germany

    Active - Recruiting

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

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe

    Schweinfurt, 97422
    Germany

    Active - Recruiting

  • Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe

    Solingen, 42653
    Germany

    Active - Recruiting

  • Diakonissen-Stiftungs-Krankenhaus Speyer, Klinik für Gynäkologie und Geburtshilfe

    Speyer, 67346
    Germany

    Site Not Available

  • Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe

    Starnberg, 82319
    Germany

    Active - Recruiting

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

    Straubing, 94315
    Germany

    Active - Recruiting

  • Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik

    Traunstein, 83278
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen, Universitätsfrauenklinik

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm, Universitätsfrauenklinik

    Ulm, 89075
    Germany

    Active - Recruiting

  • Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe

    Unna, 59423
    Germany

    Active - Recruiting

  • Schwarzwald-Baar Klinikum, Frauenklinik

    Villingen-Schwenningen, 78052
    Germany

    Active - Recruiting

  • St. Josefs-Hospital, Frauenklinik

    Wiesbaden, 65189
    Germany

    Active - Recruiting

  • Klinikum der Stadt Wolfsburg, Frauenklinik

    Wolfsburg, 38440
    Germany

    Active - Recruiting

  • Okayama University Hospital

    Okayama,
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Saitama,
    Japan

    Active - Recruiting

  • Seoul National University Hospital, Department of Obstetrics & Gynecology

    Seoul, 110-744
    Korea, Republic of

    Active - Recruiting

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