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
- Diseases
- Endometrial cancer
- 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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ostalb-Klinikum Aalen, Frauenklinik Coordinator of this site? Confirm its status | Aalen | Germany | Recruiting |
| Klinikum St. Marien Amberg, Frauenklinik Coordinator of this site? Confirm its status | Amberg | Germany | Recruiting |
| Klinikum Ansbach, Klinikum Ansbach Coordinator of this site? Confirm its status | Ansbach | Germany | Recruiting |
| Universitätsklinikum Augsburg, Frauenklinik Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Hochtaunus-Kliniken gGmbH, Frauenklinik Coordinator of this site? Confirm its status | Bad Homburg | Germany | Recruiting |
| Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde Coordinator of this site? Confirm its status | Bamberg | Germany | Recruiting |
| Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Kliniken Böblingen, Frauenklinik Coordinator of this site? Confirm its status | Böblingen | Germany | Recruiting |
| Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe Coordinator of this site? Confirm its status | Borna | Germany | Recruiting |
| Städtisches Klinikum Braunschweig gGmbH, Frauenklinik Coordinator of this site? Confirm its status | Braunschweig | Germany | Recruiting |
| Klinikum Bremen Mitte gGmbH, Frauenklinik Coordinator of this site? Confirm its status | Bremen | Germany | Recruiting |
| Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Donauwörth | Germany | Active, not recruiting |
| Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Universitätsklinikum Freiburg, Universitätsfrauenklinik Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Klinikum Fulda gAG, Frauenklinik Coordinator of this site? Confirm its status | Fulda | Germany | Recruiting |
| Klinikum Fürth, Frauenklinik Nathanstift Coordinator of this site? Confirm its status | Fürth | Germany | Recruiting |
| Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik Coordinator of this site? Confirm its status | Göttingen | Germany | Recruiting |
| Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe Coordinator of this site? Confirm its status | Greifswald | Germany | Active, not recruiting |
| Klinikum Gütersloh, Frauenklinik Coordinator of this site? Confirm its status | Gütersloh | Germany | Recruiting |
| Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Agaplesion Diakonieklinikum Hamburg, Frauenklinik Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover, Frauenklinik Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Städtisches Klinikum Karlsruhe, Frauenklinik Coordinator of this site? Confirm its status | Karlsruhe | Germany | Recruiting |
| ViDia Christliche Kliniken Karlsruhe, Frauenklinik Coordinator of this site? Confirm its status | Karlsruhe | Germany | Recruiting |
| Klinikum Mannheim GmbH, Universitäts-Frauenklinik Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Recruiting |
| Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Klinikum Offenbach GmbH, Frauenklinik Coordinator of this site? Confirm its status | Offenbach | Germany | Recruiting |
| Ortenau Klinikum St. Josefsklinik, Gynäkologie Coordinator of this site? Confirm its status | Offenburg | Germany | Recruiting |
| Klinikum Passau, Frauenklinik Coordinator of this site? Confirm its status | Passau | Germany | Recruiting |
| Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik Coordinator of this site? Confirm its status | Ravensburg | Germany | Recruiting |
| Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Schweinfurt | Germany | Recruiting |
| Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe Coordinator of this site? Confirm its status | Solingen | Germany | Recruiting |
| Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Starnberg | Germany | Recruiting |
| Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe Coordinator of this site? Confirm its status | Straubing | Germany | Recruiting |
| Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik Coordinator of this site? Confirm its status | Traunstein | Germany | Recruiting |
| Universitätsklinikum Tübingen, Universitätsfrauenklinik Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
| Universitätsklinikum Ulm, Universitätsfrauenklinik Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe Coordinator of this site? Confirm its status | Unna | Germany | Recruiting |
| Schwarzwald-Baar Klinikum, Frauenklinik Coordinator of this site? Confirm its status | Villingen-Schwenningen | Germany | Recruiting |
| St. Josefs-Hospital, Frauenklinik Coordinator of this site? Confirm its status | Wiesbaden | Germany | Recruiting |
| Klinikum der Stadt Wolfsburg, Frauenklinik Coordinator of this site? Confirm its status | Wolfsburg | Germany | Recruiting |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| Seoul National University Hospital, Department of Obstetrics & Gynecology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.