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NCT03438474Recruiting

Endometrial Cancer Lymphadenectomy Trial

Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence

Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
640 (estimated)
First submitted
31 Jan 2018
Start date
28 Mar 2018
Primary completion date
15 Feb 2028
Lead sponsor
Philipps University Marburg
NCT number
NCT03438474

What you commit to

  • Study type: Interventional
  • Planned participants: 640
  • From 28 Mar 2018 to the primary completion date, 15 Feb 2028
  • 61 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • preceding chemo-, radio, or endocrine therapy for EC
  • any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy

Other illness

  • 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

Other

  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ostalb-Klinikum Aalen, Frauenklinik
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AalenGermanyRecruiting
Klinikum St. Marien Amberg, Frauenklinik
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AmbergGermanyRecruiting
Klinikum Ansbach, Klinikum Ansbach
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AnsbachGermanyRecruiting
Universitätsklinikum Augsburg, Frauenklinik
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AugsburgGermanyRecruiting
Hochtaunus-Kliniken gGmbH, Frauenklinik
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Bad HomburgGermanyRecruiting
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
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BambergGermanyRecruiting
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
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BerlinGermanyRecruiting
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
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BerlinGermanyRecruiting
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
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BerlinGermanyRecruiting
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
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BerlinGermanyRecruiting
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
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BerlinGermanyRecruiting
Kliniken Böblingen, Frauenklinik
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BöblingenGermanyRecruiting
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
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BonnGermanyRecruiting
Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
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BornaGermanyRecruiting
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
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BraunschweigGermanyRecruiting
Klinikum Bremen Mitte gGmbH, Frauenklinik
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BremenGermanyRecruiting
Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
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CologneGermanyRecruiting
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
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DonauwörthGermanyActive, not recruiting
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
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DresdenGermanyRecruiting
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
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DüsseldorfGermanyRecruiting
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
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EssenGermanyRecruiting
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
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Frankfurt am MainGermanyRecruiting
Universitätsklinikum Freiburg, Universitätsfrauenklinik
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Freiburg im BreisgauGermanyRecruiting
Klinikum Fulda gAG, Frauenklinik
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FuldaGermanyRecruiting
Klinikum Fürth, Frauenklinik Nathanstift
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FürthGermanyRecruiting
Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
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GiessenGermanyRecruiting
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
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GöttingenGermanyRecruiting
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
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GreifswaldGermanyActive, not recruiting
Klinikum Gütersloh, Frauenklinik
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GüterslohGermanyRecruiting
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
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HalleGermanyRecruiting
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
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HamburgGermanyRecruiting
Agaplesion Diakonieklinikum Hamburg, Frauenklinik
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HamburgGermanyRecruiting
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
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HamburgGermanyRecruiting
Medizinische Hochschule Hannover, Frauenklinik
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HanoverGermanyRecruiting
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
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JenaGermanyRecruiting
Städtisches Klinikum Karlsruhe, Frauenklinik
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KarlsruheGermanyRecruiting
ViDia Christliche Kliniken Karlsruhe, Frauenklinik
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KarlsruheGermanyRecruiting
Klinikum Mannheim GmbH, Universitäts-Frauenklinik
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MannheimGermanyRecruiting
Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
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MönchengladbachGermanyRecruiting
Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
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MünchenGermanyRecruiting
Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
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MünchenGermanyRecruiting
Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
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MünchenGermanyRecruiting
Klinikum Offenbach GmbH, Frauenklinik
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OffenbachGermanyRecruiting
Ortenau Klinikum St. Josefsklinik, Gynäkologie
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OffenburgGermanyRecruiting
Klinikum Passau, Frauenklinik
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PassauGermanyRecruiting
Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
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RavensburgGermanyRecruiting
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
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RegensburgGermanyRecruiting
Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
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SchweinfurtGermanyRecruiting
Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
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SolingenGermanyRecruiting
Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
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StarnbergGermanyRecruiting
Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
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StraubingGermanyRecruiting
Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
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TraunsteinGermanyRecruiting
Universitätsklinikum Tübingen, Universitätsfrauenklinik
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TübingenGermanyRecruiting
Universitätsklinikum Ulm, Universitätsfrauenklinik
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UlmGermanyRecruiting
Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
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UnnaGermanyRecruiting
Schwarzwald-Baar Klinikum, Frauenklinik
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Villingen-SchwenningenGermanyRecruiting
St. Josefs-Hospital, Frauenklinik
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WiesbadenGermanyRecruiting
Klinikum der Stadt Wolfsburg, Frauenklinik
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WolfsburgGermanyRecruiting
Okayama University Hospital
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OkayamaJapanRecruiting
Saitama Medical University International Medical Center
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SaitamaJapanRecruiting
Seoul National University Hospital, Department of Obstetrics & Gynecology
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SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.