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Taking people in GermanyNo phase

Tests lymph node removal in endometrial cancer surgery

Tests removing pelvic and para-aortic lymph nodes in adults with early endometrial cancer.

Plain-language title generated from the registry record
Registry title: Endometrial Cancer Lymphadenectomy Trial

Key facts

Where
Aalen, Amberg, Ansbach, Augsburg, Bad Homburg, Bamberg, Berlin, Böblingen, Bonn, Borna, Braunschweig, Bremen, Cologne, Donauwörth, Dresden, Düsseldorf, Essen, Frankfurt am Main, Freiburg im Breisgau, Fulda, Fürth, Giessen, Göttingen, Greifswald, Gütersloh, Halle, Hamburg, Hanover, Jena, Karlsruhe, Mannheim, Mönchengladbach, München, Offenbach, Offenburg, Passau, Ravensburg, Regensburg, Schweinfurt, Solingen, Starnberg, Straubing, Traunstein, Tübingen, Ulm, Unna, Villingen-Schwenningen, Wiesbaden, and Wolfsburg, GermanySee the 58 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT03438474, who can take part

Where in Germany

  • Ostalb-Klinikum Aalen, FrauenklinikAalen, GermanyTaking people
  • Klinikum St. Marien Amberg, FrauenklinikAmberg, GermanyTaking people
  • Klinikum Ansbach, Klinikum AnsbachAnsbach, GermanyTaking people
  • Universitätsklinikum Augsburg, FrauenklinikAugsburg, GermanyTaking people
  • Hochtaunus-Kliniken gGmbH, FrauenklinikBad Homburg, GermanyTaking people
  • Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für FrauenheilkundeBamberg, GermanyTaking people
  • Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und GeburtshilfeBerlin, GermanyTaking people
  • Martin-Luther-Krankenhaus, Klinik für Gynäkologie und GeburtshilfeBerlin, GermanyTaking people
  • SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, FrauenklinikBerlin, GermanyTaking people
  • Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und GeburtsmedizinBerlin, GermanyTaking people
  • Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und GeburtsmedizinBerlin, GermanyTaking people
  • Kliniken Böblingen, FrauenklinikBöblingen, GermanyTaking people
  • Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. FrauenheilkundeBonn, GermanyTaking people
  • Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und GeburtshilfeBorna, GermanyTaking people
  • Städtisches Klinikum Braunschweig gGmbH, FrauenklinikBraunschweig, GermanyTaking people
  • Klinikum Bremen Mitte gGmbH, FrauenklinikBremen, GermanyTaking people
  • Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und GeburtshilfeCologne, GermanyTaking people
  • Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und GeburtshilfeDonauwörth, GermanyNo longer taking part
  • Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. GeburtshilfeDresden, GermanyTaking people
  • Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. GeburtshilfeDüsseldorf, GermanyTaking people
  • Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische OnkologieEssen, GermanyTaking people
  • Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und GeburtshilfeFrankfurt am Main, GermanyTaking people
  • Universitätsklinikum Freiburg, UniversitätsfrauenklinikFreiburg im Breisgau, GermanyTaking people
  • Klinikum Fulda gAG, FrauenklinikFulda, GermanyTaking people
  • Klinikum Fürth, Frauenklinik NathanstiftFürth, GermanyTaking people
  • Universitätsklinikum Gießen und Marburg GmbH, FrauenklinikGiessen, GermanyTaking people
  • Klinikum Göttingen, Georg-August-Universität, UniversitätsfrauenklinikGöttingen, GermanyTaking people
  • Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. GeburtshilfeGreifswald, GermanyNo longer taking part
  • Klinikum Gütersloh, FrauenklinikGütersloh, GermanyTaking people
  • Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für GynäkologieHalle, GermanyTaking people
  • Agaplesion Diakonieklinikum Hamburg, FrauenklinikHamburg, GermanyTaking people
  • Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 GynäkologieHamburg, GermanyTaking people
  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für GynäkologieHamburg, GermanyTaking people
  • Medizinische Hochschule Hannover, FrauenklinikHanover, GermanyTaking people
  • Universitätsklinikum Jena, Klinik für Frauenheilkunde und GeburtshilfeJena, GermanyTaking people
  • Städtisches Klinikum Karlsruhe, FrauenklinikKarlsruhe, GermanyTaking people
  • ViDia Christliche Kliniken Karlsruhe, FrauenklinikKarlsruhe, GermanyTaking people
  • Klinikum Mannheim GmbH, Universitäts-FrauenklinikMannheim, GermanyTaking people
  • Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und GeburtshilfeMönchengladbach, GermanyTaking people
  • Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und GeburtshilfeMünchen, GermanyTaking people
  • Klinikum Dritter Orden, Klinik für Gynäkologie und GeburtshilfeMünchen, GermanyTaking people
  • Klinikum rechts der Isar der Technischen Universität, Frauen- und PoliklinikMünchen, GermanyTaking people
  • Klinikum Offenbach GmbH, FrauenklinikOffenbach, GermanyTaking people
  • Ortenau Klinikum St. Josefsklinik, GynäkologieOffenburg, GermanyTaking people
  • Klinikum Passau, FrauenklinikPassau, GermanyTaking people
  • Oberschwabenklinik Krankenhaus St. Elisabeth, FrauenklinikRavensburg, GermanyTaking people
  • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. GeburtshilfeRegensburg, GermanyTaking people
  • Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und GeburtshilfeSchweinfurt, GermanyTaking people
  • Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. GeburtshilfeSolingen, GermanyTaking people
  • Klinikum Starnberg, Klinik für Frauenheilkunde und GeburtshilfeStarnberg, GermanyTaking people
  • Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und GeburtshilfeStraubing, GermanyTaking people
  • Kreiskliniken Traunstein-Trostberg GmbH, FrauenklinikTraunstein, GermanyTaking people
  • Universitätsklinikum Tübingen, UniversitätsfrauenklinikTübingen, GermanyTaking people
  • Universitätsklinikum Ulm, UniversitätsfrauenklinikUlm, GermanyTaking people
  • Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und GeburtshilfeUnna, GermanyTaking people
  • Schwarzwald-Baar Klinikum, FrauenklinikVillingen-Schwenningen, GermanyTaking people
  • St. Josefs-Hospital, FrauenklinikWiesbaden, GermanyTaking people
  • Klinikum der Stadt Wolfsburg, FrauenklinikWolfsburg, GermanyTaking people

Questions to ask the study team

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  4. What happens if I want to stop?
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Trial details

Who runs it
Philipps University Marburg
Trial code
NCT03438474
Record updated
25 November 2024
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: preceding chemo-, radio, or endocrine therapy for EC; any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy; sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor); evidence of extrauterine disease by visual inspection; 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; stage pT1a, G1 or G2 tumors of type 1 histology; EC of FIGO stages III or IV (except for microscopical lymph node metastases); recurrent EC; any medical history indicating excessive peri-operative risk; 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).

ClinicalTrials.gov NCT03438474