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Endometrial Cancer Lymphadenectomy Trial (ECLAT)

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ClinicalTrials.gov Identifier: NCT03438474
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
German Cancer Aid
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer of Endometrium Stage I Cancer of Endometrium Stage II Procedure: Standard surgical procedure for endometrial cancer Procedure: systematic lymphadenectomy (LNE) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : February 15, 2028
Estimated Study Completion Date : February 15, 2029

Arm Intervention/treatment
Active Comparator: Arm A standard surgical procedure

Standard surgical procedure for endometrial cancer:

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

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

Experimental: Arm B systematic lymphadenectomy (LNE)

In addition to standard procedures as defined for Arm A:

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

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

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




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 60 months ]
    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence


Secondary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: 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 ]
    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival

  2. Disease specific survival (DSS) [ Time Frame: 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 ]
    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival

  3. Assessment of serious complications [ Time Frame: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months ]
    Assessment of perioperative complications and site effects of LNE

  4. EORTC QLQ-C30 [ Time Frame: 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 ]
    Health related Quality of life (QoL)

  5. EORTC QLQ-EN24 [ Time Frame: 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 ]
    Health related Quality of life (QoL)

  6. Number of resected lymph nodes [ Time Frame: during surgery ]
    resected pelvic and para-aortic lymph nodes



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438474


Contacts
Contact: Günter Emons, Professor MD 0049 (0) 551-3966501 emons@med.uni-goettingen.de
Contact: Philipp Harter, MD 0049 (0) 201 1743-4511 p.harter@kliniken-essen-mitte.de

Locations
Germany
Ostalb-Klinikum Aalen, Frauenklinik Recruiting
Aalen, Germany, 73430
Contact: Karsten Gnauert, MD    0049 (0) 7361-551401    karsten.gnauert@kliniken-ostalb.de   
Klinikum St. Marien Amberg, Frauenklinik Recruiting
Amberg, Germany, 92224
Contact: Thomas Papathemelis, MD    0049 (0) 9621-381381    papathemelis.thomas@klinikum-amberg.de   
Klinikum Ansbach, Klinikum Ansbach Recruiting
Ansbach, Germany, 91522
Contact: Bernd Hornbacher, MD    0049 (0) 981-484 2256    bernd.hornbacher@anregiomed.de   
Hochtaunus-Kliniken gGmbH, Frauenklinik Recruiting
Bad Homburg, Germany, 61325
Contact: Dominik Denschlag, Professor MD    0049 (0) 6172 142 580    dominik.denschlag@hochtaunus-kliniken.de   
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik Recruiting
Berlin, Germany, 10365
Contact: Jens-Peter Scharf, MD    0049 (0) 30-55182411    j.scharf@sana-kl.de   
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Berlin, Germany, 13353
Contact: Mustafa Zelal Muallem, MD    0049 (0) 30-450 664373    mustafa-zelal.muallem@charite.de   
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe Recruiting
Berlin, Germany, 14193
Contact: Uwe Ulrich, Professor MD    0049 (0) 30-8955 83311    u.ulrich@mlk-berlin.de   
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde Recruiting
Bonn, Germany, 53105
Contact: Eva Egger, MD    0049 (0) 228-287 15447    eva-katharina.egger@ukb.uni-bonn.de   
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik Not yet recruiting
Braunschweig, Germany, 38114
Contact: Heiko Franz, MD    0049 (0) 531-595 3260    h.franz@klinikum-braunschweig.de   
Klinikum Bremen Mitte gGmbH, Frauenklinik Recruiting
Bremen, Germany, 28177
Contact: Mustafa Aydogdu, MD    0049 (0) 421-497 5351    mustafa.aydogdu@klinikum-bremen-mitte.de   
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Donauwörth, Germany, 86609
Contact: Armin Both, MD    0049 (0) 906-782 1031    gynaekologie@donkliniken.de   
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe Recruiting
Dresden, Germany, 01304
Contact: Pauline Wimberger, Professor MD    0049 (0) 351-458 16728    pauline.wimberger@uniklinikum-dresden.de   
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe Recruiting
Düsseldorf, Germany, 40489
Contact: Björn Lampe, Professor MD    0049 (0) 211-409 2519    lampe@kaiserswerther-diakonie.de   
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie Recruiting
Essen, Germany, 45136
Contact: Philipp Harter, MD    0049 (0) 201-1743-4511    p.harter@kliniken-essen-mitte.de   
Universitätsklinikum Essen, Universitätsfrauenklinik Not yet recruiting
Essen, Germany, 45147
Contact: Paul Buderath, MD    0049 (0) 201-723 85293    paul.buderath@uk-essen.de   
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe Not yet recruiting
Frankfurt/Main, Germany, 60590
Contact: Ahmed El-Balat, MD    0049 (0) 69 6301 7438    ahmed.el-balat@kgu.de   
Universitätsklinikum Freiburg, Universitätsfrauenklinik Not yet recruiting
Freiburg, Germany, 79106
Contact: Maximilian Klar, MD    0049 (0) 761-270 30010    maximilian.klar@uniklinik-freiburg.de   
Klinikum Fürth, Frauenklinik Nathanstift Recruiting
Fürth, Germany, 90766
Contact: Volker Hanf, Professor MD    0049 (0) 911-7580 1301    volker.hanf@klinikum-fuerth.de   
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe Recruiting
Greifswald, Germany, 17475
Contact: Alexander Mustea, Professor MD    0049 (0) 3834-86 22243    mustea@uni-greifswald.de   
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik Recruiting
Göttingen, Germany, 37075
Contact: Günter Emons, Professor MD    0049 (0) 551-3966501    emons@med.uni-goettingen.de   
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie Not yet recruiting
Halle/Saale, Germany, 06120
Contact: Hans-Georg Strauß, MD    0049 (0) 345-557 1888    hans.strauss@uk-halle.de   
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie Recruiting
Hamburg, Germany, 20246
Contact: Barbara Schmalfeldt, Professor MD    0049 (0) 40-7410 52510    b.schmalfeldt@uke.de   
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie Recruiting
Hamburg, Germany, 22457
Contact: Uwe Herwig, MD    0049 (0) 40-5588-6752    uwe.herwig@albertinen.de   
Medizinische Hochschule Hannover, Frauenklinik Not yet recruiting
Hannover, Germany, 30625
Contact: Peter Hillemanns, Professor MD    0049 (0) 511-532 6144    hillemanns.peter@mh-hannover.de   
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe Not yet recruiting
Jena, Germany, 07747
Contact: Ingo B. Runnebaum, Professor MD    0049 (0) 3641-933063    ingo.runnebaum@med.uni-jena.de   
Städtisches Klinikum Karlsruhe, Frauenklinik Recruiting
Karlsruhe, Germany, 73133
Contact: Andreas Müller, Professor MD    0049 (0) 721-974 2401    andreas.mueller.fk@klinikum-karlsruhe.de   
Universitätsklinikum Köln, Klinik für Gynäkologie und Geburtshilfe Not yet recruiting
Köln, Germany, 50931
Contact: Peter Mallmann, Professor MD    0049 (0) 221-4784940    peter.mallmann@uk-koeln.de   
Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Recruiting
München, Germany, 81377
Contact: Julia Gallwas, Professor MD    0049 (0) 89-4400-73723    Julia.Gallwas@med.uni-muenchen.de   
Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik Recruiting
München, Germany, 81675
Contact: Christine Brambs, MD    0049 (0) 89-4140 2433    christine.brambs@tum.de   
Klinikum Nürnberg Nord, Klinik für Frauenheilkunde Recruiting
Nürnberg, Germany, 90419
Contact: Cosima Brucker, Professor MD    0049 (0) 911-398 2222    cosima.brucker@klinikum-nuernberg.de   
Klinikum Offenbach GmbH, Frauenklinik Recruiting
Offenbach, Germany, 63069
Contact: Jens Kosse, MD    0049 (0) 69-8405 7312    jens.kosse@sana.de   
Ortenau Klinikum St. Josefsklinik, Gynäkologie Recruiting
Offenburg, Germany, 77654
Contact: Matthias Frank    0049 (0) 781-472 3503    matthias.frank@og.ortenau-klinikum.de   
Klinikum Passau, Frauenklinik Recruiting
Passau, Germany, 94032
Contact: Martin Dengler, MD    0049 (0) 851-5300 2297    martin.dengler@klinikum-passau.de   
Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik Recruiting
Ravensburg, Germany, 88212
Contact: Martina Gropp-Meier, MD    0049 (0) 751-87 2447    martina.gropp-meier@oberschwabenklinik.de   
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe Recruiting
Regensburg, Germany, 93053
Contact: Stefan Buchholz, Professor MD    0049 (0) 941-782 3401    sbuchholz@caritasstjosef.de   
Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe Recruiting
Schweinfurt, Germany, 97422
Contact: Michael Weigel, Professor MD    0049 (0) 9721-720 2132    mweigel@leopoldina.de   
Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe Recruiting
Solingen, Germany, 42653
Contact: Sebastian Hentsch, MD    0049 (0) 212-547 2371    hentsch@klinikumsolingen.de   
Diakonissen-Stiftungs-Krankenhaus Speyer, Klinik für Gynäkologie und Geburtshilfe Not yet recruiting
Speyer, Germany, 67346
Contact: Uwe Eissler, MD    0049 (0) 6232-220    uwe.eissler@diakonissen.de   
Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Starnberg, Germany, 82319
Contact: Christoph Anthuber, Professor MD    0049 (0) 8151-18 2312    christoph.anthuber@klinikum-starnberg.de   
Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Straubing, Germany, 94315
Contact: Carsten Scholz, MD    0049 (0) 9421-710 1450    Carsten.Scholz@klinikum-straubing.de   
Universitätsklinikum Tübingen, Universitätsfrauenklinik Recruiting
Tübingen, Germany, 72076
Contact: Stefan Kommoss, Professor MD    0049 (0) 7071-29 82211    stefan.kommoss@med.uni-tuebingen.de   
Universitätsklinikum Ulm, Universitätsfrauenklinik Recruiting
Ulm, Germany, 89075
Contact: Nikolaus de Gregorio, MD    0049 (0) 731-500 58688    nikolaus.degregorio@uniklinik-ulm.de   
Katharinen-Hospital Unna, Klinik für Gynäkologie und Geburtshilfe Recruiting
Unna, Germany, 59423
Contact: Kunibert Latos, MD    0049 (0) 2303-100 2068    k.latos@hospitalverbund.de   
Schwarzwald-Baar Klinikum, Frauenklinik Recruiting
Villingen-Schwenningen, Germany, 78052
Contact: Kurt Seeborg    0049 (0) 7721-933116    kurt.seeborg@sbk-vs.de   
St. Josefs-Hospital, Frauenklinik Recruiting
Wiesbaden, Germany, 65189
Contact: Boris Gabriel, Professor MD    0049 (0) 611-177 1512    bgabriel@joho.de   
Klinikum der Stadt Wolfsburg, Frauenklinik Recruiting
Wolfsburg, Germany, 38440
Contact: Karl Ulrich Petry, Professor MD    0049 (0) 5361-80 1270    gyn@klinikum.wolfsburg.de   
Sponsors and Collaborators
Philipps University Marburg Medical Center
German Cancer Aid
Investigators
Principal Investigator: Günter Emons, Professor MD Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik

Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03438474     History of Changes
Other Study ID Numbers: AGO-OP.6 KKS 228
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female