Ireland
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Recruiting Not applicable

Endometrial Cancer Lymphadenectomy Trial

NCT03438474 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2018-03-28
Last updated
2024-11-25

Condition(s) studied

Cancer of Endometrium Stage ICancer of Endometrium Stage II

Investigational drug(s) / intervention(s)

Standard surgical procedure for endometrial cancersystematic lymphadenectomy (LNE)

Standard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

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

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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Overall survival (OS) — 60 months
    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence

Trial sites (61)

FacilityCityRegionStatus
Ostalb-Klinikum Aalen, Frauenklinik Aalen Germany Recruiting
Klinikum St. Marien Amberg, Frauenklinik Amberg Germany Recruiting
Klinikum Ansbach, Klinikum Ansbach Ansbach Germany Recruiting
Universitätsklinikum Augsburg, Frauenklinik Augsburg Germany Recruiting
Hochtaunus-Kliniken gGmbH, Frauenklinik Bad Homburg Germany Recruiting
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde Bamberg Germany Recruiting
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik Berlin Germany Recruiting
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin Berlin Germany Recruiting
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe Berlin Germany Recruiting
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin Berlin Germany Recruiting
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe Berlin Germany Recruiting
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde Bonn Germany Recruiting
Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe Borna Germany Recruiting
Kliniken Böblingen, Frauenklinik Böblingen Germany Recruiting
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik Braunschweig Germany Recruiting
Klinikum Bremen Mitte gGmbH, Frauenklinik Bremen Germany Recruiting
Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe Cologne Germany Recruiting
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe Donauwörth Germany Active Not Recruiting
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe Dresden Germany Recruiting
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe Düsseldorf Germany Recruiting
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie Essen Germany Recruiting
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe Frankfurt am Main Germany Recruiting
Universitätsklinikum Freiburg, Universitätsfrauenklinik Freiburg im Breisgau Germany Recruiting
Klinikum Fulda gAG, Frauenklinik Fulda Germany Recruiting
Klinikum Fürth, Frauenklinik Nathanstift Fürth Germany Recruiting
Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik Giessen Germany Recruiting
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik Göttingen Germany Recruiting
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe Greifswald Germany Active Not Recruiting
Klinikum Gütersloh, Frauenklinik Gütersloh Germany Recruiting
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie Halle Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie Hamburg Germany Recruiting
Agaplesion Diakonieklinikum Hamburg, Frauenklinik Hamburg Germany Recruiting
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie Hamburg Germany Recruiting
Medizinische Hochschule Hannover, Frauenklinik Hanover Germany Recruiting
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe Jena Germany Recruiting
Städtisches Klinikum Karlsruhe, Frauenklinik Karlsruhe Germany Recruiting
ViDia Christliche Kliniken Karlsruhe, Frauenklinik Karlsruhe Germany Recruiting
Klinikum Mannheim GmbH, Universitäts-Frauenklinik Mannheim Germany Recruiting
Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe Mönchengladbach Germany Recruiting
Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe München Germany Recruiting

+ 21 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03438474 on ClinicalTrials.gov ↗ ← All trials in Japan