Clinical trial NCT03438474: Endometrial Cancer Lymphadenectomy Trial
Official title: Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Endometrium Stage I
Cancer of Endometrium Stage II
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
First posted: 2018-02-19
Enrollment: 640
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 outcomes:
measure: Overall survival (OS)
timeFrame: 60 months
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months
measure: Disease specific survival (DSS)
timeFrame: 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months
measure: Assessment of serious complications
timeFrame: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
measure: EORTC QLQ-C30
timeFrame: Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months
measure: EORTC QLQ-EN24
timeFrame: Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months
measure: Number of resected lymph nodes
timeFrame: during surgery
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Ostalb-Klinikum Aalen, Frauenklinik
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg, Frauenklinik
city: Ansbach
country: Germany
facility: Klinikum Ansbach, Klinikum Ansbach
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg, Frauenklinik
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken gGmbH, Frauenklinik
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
city: Berlin
country: Germany
facility: SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
city: Berlin
country: Germany
facility: Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
city: Berlin
country: Germany
facility: Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
city: Berlin
country: Germany
facility: Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
city: Borna
country: Germany
facility: Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
city: Bremen
country: Germany
facility: Klinikum Bremen Mitte gGmbH, Frauenklinik
city: Böblingen
country: Germany
facility: Kliniken Böblingen, Frauenklinik
city: Donauwörth
country: Germany
facility: Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
city: Düsseldorf
country: Germany
facility: Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
city: Essen
country: Germany
facility: Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Universitätsfrauenklinik
city: Fulda
country: Germany
facility: Klinikum Fulda gAG, Frauenklinik
city: Fürth
country: Germany
facility: Klinikum Fürth, Frauenklinik Nathanstift
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
city: Greifswald
country: Germany
facility: Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
city: Göttingen
country: Germany
facility: Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
city: Gütersloh
country: Germany
facility: Klinikum Gütersloh, Frauenklinik
city: Halle/Saale
country: Germany
facility: Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
city: Hamburg
country: Germany
facility: Agaplesion Diakonieklinikum Hamburg, Frauenklinik
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Frauenklinik
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe, Frauenklinik
city: Karlsruhe
country: Germany
facility: ViDia Christliche Kliniken Karlsruhe, Frauenklinik
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH, Universitäts-Frauenklinik
city: Mönchengladbach
country: Germany
facility: Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
city: München
country: Germany
facility: Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
city: München
country: Germany
facility: Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
city: Offenbach
country: Germany
facility: Klinikum Offenbach GmbH, Frauenklinik
city: Offenburg
country: Germany
facility: Ortenau Klinikum St. Josefsklinik, Gynäkologie
city: Passau
country: Germany
facility: Klinikum Passau, Frauenklinik
city: Ravensburg
country: Germany
facility: Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
city: Schweinfurt
country: Germany
facility: Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
city: Solingen
country: Germany
facility: Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
city: Starnberg
country: Germany
facility: Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
city: Straubing
country: Germany
facility: Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
city: Traunstein
country: Germany
facility: Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Universitätsfrauenklinik
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Universitätsfrauenklinik
city: Unna
country: Germany
facility: Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum, Frauenklinik
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital, Frauenklinik
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg, Frauenklinik
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Department of Obstetrics & Gynecology
Study officials:
affiliation: Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie
name: Philipp Harter, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emons G, Kim JW, Weide K, de Gregorio N, Wimberger P, Trillsch F, Gabriel B, Denschlag D, Kommoss S, Aydogdu M, Papathemelis T, Gropp-Meier M, Muallem MZ, Kuhn C, Muller A, Frank M, Weigel M, Bronger H, Lampe B, Rau J, Schade-Brittinger C, Harter P. Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6). Int J Gynecol Cancer. 2021 Jul;31(7):1075-1079. doi: 10.1136/ijgc-2021-002703.