Endometrial Cancer Lymphadenectomy Trial (ECLAT)

May 9, 2023 updated by: Philipps University Marburg Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

640

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Günter Emons, Professor MD
Phone Number: 0049 (0) 551-39 66532
Email: emons@med.uni-goettingen.de

Study Contact Backup

Name: Philipp Harter, MD
Phone Number: 0049 (0) 201 1743-4511
Email: p.harter@kliniken-essen-mitte.de

Study Locations

Germany
- - Aalen, Germany, 73430
    - Recruiting
    - Ostalb-Klinikum Aalen, Frauenklinik
    - Contact:
      
      Karsten Gnauert, MD
      
      Phone Number: 0049 (0) 7361-551401
      
      Email: karsten.gnauert@kliniken-ostalb.de
  - Amberg, Germany, 92224
    - Recruiting
    - Klinikum St. Marien Amberg, Frauenklinik
    - Contact:
      
      Thomas Papathemelis, MD
      
      Phone Number: 0049 (0) 9621-381381
      
      Email: papathemelis.thomas@klinikum-amberg.de
  - Ansbach, Germany, 91522
    - Recruiting
    - Klinikum Ansbach, Klinikum Ansbach
    - Contact:
      
      Martin Koch, MD
      
      Phone Number: 0049 (0) 981-484 2256
      
      Email: martin.koch@anregiomed.de
  - Augsburg, Germany, 86156
    - Recruiting
    - Universitätsklinikum Augsburg, Frauenklinik
    - Contact:
      
      Christian Dannecker, Professor MD
      
      Phone Number: 0049 (0) 821-400-2331
      
      Email: christian.dannecker@med.uni-augsburg.de
  - Bad Homburg, Germany, 61325
    - Recruiting
    - Hochtaunus-Kliniken gGmbH, Frauenklinik
    - Contact:
      
      Dominik Denschlag, Professor MD
      
      Phone Number: 0049 (0) 6172 142 580
      
      Email: dominik.denschlag@hochtaunus-kliniken.de
  - Bamberg, Germany, 96049
    - Recruiting
    - Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
    - Contact:
      
      Hans-Martin Enzinger, MD
      
      Phone Number: 0049 (0) 951-503 15730
      
      Email: hans-martin.enzinger@sozialstiftung-bamberg.de
  - Berlin, Germany, 10365
    - Recruiting
    - SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
    - Contact:
      
      Jens-Peter Scharf, MD
      
      Phone Number: 0049 (0) 30-55182411
      
      Email: j.scharf@sana-kl.de
  - Berlin, Germany, 12157
    - Recruiting
    - Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
    - Contact:
      
      Mandy Mangler, MD
      
      Phone Number: 0049 (0) 30-130202402
      
      Email: mandy.mangler@vivantes.de
  - Berlin, Germany, 13353
    - Recruiting
    - Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Mustafa Zelal Muallem, MD
      
      Phone Number: 0049 (0) 30-450 664373
      
      Email: mustafa-zelal.muallem@charite.de
  - Berlin, Germany, 13509
    - Recruiting
    - Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
    - Contact:
      
      Zaher Halwani, MD
      
      Phone Number: 0049 (0) 30-130121261
      
      Email: zaher.halwani@vivantes.de
  - Berlin, Germany, 14193
    - Recruiting
    - Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
    - Contact:
      
      Uwe Ulrich, Professor MD
      
      Phone Number: 0049 (0) 30-8955 83311
      
      Email: u.ulrich@mlk-berlin.de
  - Bonn, Germany, 53105
    - Recruiting
    - Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
    - Contact:
      
      Eva Egger, MD
      
      Phone Number: 0049 (0) 228-287 15447
      
      Email: eva-katharina.egger@ukb.uni-bonn.de
  - Borna, Germany, 04552
    - Recruiting
    - Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
    - Contact:
      
      Jens Einenkel, MD
      
      Phone Number: 0049 (0) 3433 21-1400
      
      Email: jens.einenkel@sana.de
  - Braunschweig, Germany, 38114
    - Recruiting
    - Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
    - Contact:
      
      Heiko Franz, MD
      
      Phone Number: 0049 (0) 531-595 3260
      
      Email: h.franz@klinikum-braunschweig.de
  - Bremen, Germany, 28177
    - Recruiting
    - Klinikum Bremen Mitte gGmbH, Frauenklinik
    - Contact:
      
      Mustafa Aydogdu, MD
      
      Phone Number: 0049 (0) 421-497 5351
      
      Email: mustafa.aydogdu@klinikum-bremen-mitte.de
  - Böblingen, Germany, 71032
    - Recruiting
    - Kliniken Böblingen, Frauenklinik
    - Contact:
      
      Stefan Renner, Professor MD
      
      Phone Number: 0049 (0) 7031-668-22201
      
      Email: S.Renner@klinikverbund-suedwest.de
  - Donauwörth, Germany, 86609
    - Active, not recruiting
    - Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
  - Dresden, Germany, 01304
    - Recruiting
    - Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
    - Contact:
      
      Pauline Wimberger, Professor MD
      
      Phone Number: 0049 (0) 351-458 16728
      
      Email: pauline.wimberger@uniklinikum-dresden.de
  - Düsseldorf, Germany, 40489
    - Recruiting
    - Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
    - Contact:
      
      Björn Lampe, Professor MD
      
      Phone Number: 0049 (0) 211-409 2519
      
      Email: lampe@kaiserswerther-diakonie.de
  - Essen, Germany, 45136
    - Recruiting
    - Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
    - Contact:
      
      Philipp Harter, MD
      
      Phone Number: 0049 (0) 201-1743-4511
      
      Email: p.harter@kliniken-essen-mitte.de
  - Frankfurt/Main, Germany, 60590
    - Recruiting
    - Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
    - Contact:
      
      Ahmed El-Balat, MD
      
      Phone Number: 0049 (0) 69 6301 7438
      
      Email: ahmed.el-balat@kgu.de
  - Freiburg, Germany, 79106
    - Recruiting
    - Universitätsklinikum Freiburg, Universitätsfrauenklinik
    - Contact:
      
      Maximilian Klar, MD
      
      Phone Number: 0049 (0) 761-270 30010
      
      Email: maximilian.klar@uniklinik-freiburg.de
  - Fulda, Germany, 36043
    - Recruiting
    - Klinikum Fulda gAG, Frauenklinik
    - Contact:
      
      Thomas Hawighorst, MD
      
      Phone Number: 0049 (0) 661-84 5901
      
      Email: Thomas.Hawighorst@klinikum-fulda.de
  - Fürth, Germany, 90766
    - Recruiting
    - Klinikum Fürth, Frauenklinik Nathanstift
    - Contact:
      
      Volker Hanf, Professor MD
      
      Phone Number: 0049 (0) 911-7580 1301
      
      Email: volker.hanf@klinikum-fuerth.de
  - Gießen, Germany, 35392
    - Recruiting
    - Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
    - Contact:
      
      Ivo Meinhold-Heerlein, Professor MD
      
      Phone Number: 0049 (0) 641-985-45100
      
      Email: ivo.meinhold-heerlein@gyn.med.uni-giessen.de
  - Greifswald, Germany, 17475
    - Active, not recruiting
    - Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
  - Göttingen, Germany, 37075
    - Recruiting
    - Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
    - Contact:
      
      Gerd Bauerschmitz, MD
      
      Phone Number: 0049 (0) 551-39 66582
      
      Email: gerd.bauerschmitz@med.uni-goettingen.de
  - Gütersloh, Germany, 33332
    - Recruiting
    - Klinikum Gütersloh, Frauenklinik
    - Contact:
      
      Wencke Ruhwedel, MD
      
      Phone Number: 0049 (0) 5241-832-4102
      
      Email: wencke.ruhwedel@klinikum-guetersloh.de
  - Halle/Saale, Germany, 06120
    - Recruiting
    - Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
    - Contact:
      
      Nancy Papendick, MD
      
      Phone Number: 0049 (0) 345-557 1323
      
      Email: nancy.papendick@uk-halle.de
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
    - Contact:
      
      Barbara Schmalfeldt, Professor MD
      
      Phone Number: 0049 (0) 40-7410 52510
      
      Email: b.schmalfeldt@uke.de
  - Hamburg, Germany, 20259
    - Recruiting
    - Agaplesion Diakonieklinikum Hamburg, Frauenklinik
    - Contact:
      
      Christoph Lindner, Professor MD
      
      Phone Number: 0049 (0) 40-790 20 2500
      
      Email: christoph.lindner@d-k-h.de
  - Hamburg, Germany, 22457
    - Recruiting
    - Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
    - Contact:
      
      Uwe Herwig, MD
      
      Phone Number: 0049 (0) 40-5588-6752
      
      Email: uwe.herwig@albertinen.de
  - Hannover, Germany, 30625
    - Recruiting
    - Medizinische Hochschule Hannover, Frauenklinik
    - Contact:
      
      Peter Hillemanns, Professor MD
      
      Phone Number: 0049 (0) 511-532 6144
      
      Email: hillemanns.peter@mh-hannover.de
  - Jena, Germany, 07747
    - Recruiting
    - Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Ingo B. Runnebaum, Professor MD
      
      Phone Number: 0049 (0) 3641-933063
      
      Email: ingo.runnebaum@med.uni-jena.de
  - Karlsruhe, Germany, 73133
    - Recruiting
    - Städtisches Klinikum Karlsruhe, Frauenklinik
    - Contact:
      
      Andreas Müller, Professor MD
      
      Phone Number: 0049 (0) 721-974 2401
      
      Email: andreas.mueller.fk@klinikum-karlsruhe.de
  - Karlsruhe, Germany, 76135
    - Recruiting
    - ViDia Christliche Kliniken Karlsruhe, Frauenklinik
    - Contact:
      
      Oliver Tomé, MD
      
      Phone Number: 0049 (0) 721-8108 9003
      
      Email: oliver.tome@vincentius-ka.de
  - Köln, Germany, 51103
    - Recruiting
    - Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
    - Contact:
      
      Dirk Michael Forner, MD
      
      Phone Number: 0049 (0) 221-8289-5485
      
      Email: dirk.forner@evkk.de
  - Mannheim, Germany, 68167
    - Recruiting
    - Klinikum Mannheim GmbH, Universitäts-Frauenklinik
    - Contact:
      
      Benjamin Tuschy, Professor MD
      
      Phone Number: 0049 (0) 621-383-4176
      
      Email: benjamin.tuschy@umm.de
  - Mönchengladbach, Germany, 41061
    - Recruiting
    - Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Darius Salehin, MD
      
      Phone Number: 0049 (0) 2161-981 1105
      
      Email: darius.salehin@mg.johanniter-kliniken.de
  - München, Germany, 80638
    - Recruiting
    - Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
    - Contact:
      
      Franz Edler von Koch, MD
      
      Phone Number: 0049 (0)89-17952501
      
      Email: franz.koch@dritter-orden.de
  - München, Germany, 81377
    - Recruiting
    - Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Fabian Trillsch, MD
      
      Phone Number: 0049 (0) 89-4400-73723
      
      Email: Fabian.Trillsch@med.uni-muenchen.de
  - München, Germany, 81675
    - Recruiting
    - Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
    - Contact:
      
      Holger Bronger, MD
      
      Phone Number: 0049 (0) 89-4140 2433
      
      Email: holger.bronger@mri.tum.de
  - Offenbach, Germany, 63069
    - Recruiting
    - Klinikum Offenbach GmbH, Frauenklinik
    - Contact:
      
      Jens Kosse, MD
      
      Phone Number: 0049 (0) 69-8405 7312
      
      Email: jens.kosse@sana.de
  - Offenburg, Germany, 77654
    - Recruiting
    - Ortenau Klinikum St. Josefsklinik, Gynäkologie
    - Contact:
      
      Matthias Frank
      
      Phone Number: 0049 (0) 781-472 3503
      
      Email: matthias.frank@og.ortenau-klinikum.de
  - Passau, Germany, 94032
    - Recruiting
    - Klinikum Passau, Frauenklinik
    - Contact:
      
      Martin Dengler, MD
      
      Phone Number: 0049 (0) 851-5300 2297
      
      Email: martin.dengler@klinikum-passau.de
  - Ravensburg, Germany, 88212
    - Recruiting
    - Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
    - Contact:
      
      Martina Gropp-Meier, MD
      
      Phone Number: 0049 (0) 751-87 2447
      
      Email: martina.gropp-meier@oberschwabenklinik.de
  - Regensburg, Germany, 93053
    - Recruiting
    - Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
    - Contact:
      
      Stephan Seitz, MD
      
      Phone Number: 0049 (0) 941-782 3403
      
      Email: sseitz@caritasstjosef.de
  - Schweinfurt, Germany, 97422
    - Recruiting
    - Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Michael Weigel, Professor MD
      
      Phone Number: 0049 (0) 9721-720 2132
      
      Email: mweigel@leopoldina.de
  - Solingen, Germany, 42653
    - Recruiting
    - Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
    - Contact:
      
      Sebastian Hentsch, MD
      
      Phone Number: 0049 (0) 212-547 2371
      
      Email: hentsch@klinikumsolingen.de
  - Starnberg, Germany, 82319
    - Recruiting
    - Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Christoph Anthuber, Professor MD
      
      Phone Number: 0049 (0) 8151-18 2312
      
      Email: christoph.anthuber@klinikum-starnberg.de
  - Straubing, Germany, 94315
    - Recruiting
    - Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
    - Contact:
      
      Carsten Scholz, MD
      
      Phone Number: 0049 (0) 9421-710 1450
      
      Email: Carsten.Scholz@klinikum-straubing.de
  - Traunstein, Germany, 83278
    - Recruiting
    - Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
    - Contact:
      
      Christian Schindlbeck, MD
      
      Phone Number: 0049 (0) 861-705 1231
      
      Email: christian.schindlbeck@kliniken-sob.de
  - Tübingen, Germany, 72076
    - Recruiting
    - Universitätsklinikum Tübingen, Universitätsfrauenklinik
    - Contact:
      
      Stefan Kommoss, Professor MD
      
      Phone Number: 0049 (0) 7071-29 82211
      
      Email: stefan.kommoss@med.uni-tuebingen.de
  - Ulm, Germany, 89075
    - Recruiting
    - Universitätsklinikum Ulm, Universitätsfrauenklinik
    - Contact:
      
      Fabienne Schochter, MD
      
      Phone Number: 0049 (0) 731-500 58688
      
      Email: fabienne.schochter@uniklinik-ulm.de
  - Unna, Germany, 59423
    - Recruiting
    - Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
    - Contact:
      
      Cristin Kühn, MD
      
      Phone Number: 0049 (0) 2303-100 2071
      
      Email: c.kuehn@hospitalverbund.de
  - Villingen-Schwenningen, Germany, 78052
    - Recruiting
    - Schwarzwald-Baar Klinikum, Frauenklinik
    - Contact:
      
      Kurt Seeborg
      
      Phone Number: 0049 (0) 7721-933116
      
      Email: kurt.seeborg@sbk-vs.de
  - Wiesbaden, Germany, 65189
    - Recruiting
    - St. Josefs-Hospital, Frauenklinik
    - Contact:
      
      Boris Gabriel, Professor MD
      
      Phone Number: 0049 (0) 611-177 1512
      
      Email: bgabriel@joho.de
  - Wolfsburg, Germany, 38440
    - Recruiting
    - Klinikum der Stadt Wolfsburg, Frauenklinik
    - Contact:
      
      Clemens Liebrich, MD
      
      Phone Number: 0049 (0) 5361-80 3813
      
      Email: clemens.liebrich@klinikum.wolfsburg.de
Japan
- - Okayama, Japan
    - Recruiting
    - Okayama University Hospital
    - Contact:
      
      Shoji Nagao, MD
  - Saitama, Japan
    - Recruiting
    - Saitama Medical University International Medical Center
    - Contact:
      
      Yabuno Akira, MD
Korea, Republic of
- - Seoul, Korea, Republic of, 110-744
    - Recruiting
    - Seoul National University Hospital, Department of Obstetrics & Gynecology
    - Contact:
      
      Jae Weon Kim, Professor MD
      
      Phone Number: 0082-2-2072-2821
      
      Email: kjwksh@snu.ac.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

stage pT1a, G1 or G2 tumors of type 1 histology
sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
EC of FIGO stages III or IV (except for microscopical lymph node metastases)
evidence of extrauterine disease by visual inspection
recurrent EC
preceding chemo-, radio, or endocrine therapy for EC
any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
any medical history indicating excessive peri-operative risk
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
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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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 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
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	during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
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)	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
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)	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
Number of resected lymph nodes Time Frame: during surgery	resected pelvic and para-aortic lymph nodes	during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Collaborators

German Cancer Aid

Investigators

Principal Investigator: Philipp Harter, MD, Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2018

Primary Completion (Anticipated)

February 15, 2028

Study Completion (Anticipated)

February 15, 2029

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

AGO-OP.6 KKS 228

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer of Endometrium Stage I

Eli Lilly and Company
Gynecologic Oncology Group

Completed

A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Neoplasms | Urogenital Neoplasms | Neoplasms by Site | Uterine Neoplasms | Genital Neoplasms, Female | Endometrial Neoplasms | Endometrial Cancer | Endometrium Cancer | Cancer of Endometrium | Cancer of the Endometrium | Neoplasms, Endometrial

United States
Ohio State University Comprehensive Cancer Center

Completed

Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.

Tongue Cancer | Salivary Gland Squamous Cell Carcinoma | Stage I Salivary Gland Cancer | Stage I Squamous Cell Carcinoma of the Hypopharynx | Stage I Squamous Cell Carcinoma of the Larynx | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Nasopharynx and other conditions

United States
Dana-Farber Cancer Institute
MedWaves, Inc

Not yet recruiting

Avecure Flexible Microwave Ablation Probe For Lung Nodules

Lung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung Cancer

United States
Roswell Park Cancer Institute

Completed

Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer

Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Recurrent Metastatic Squamous Neck Cancer With Occult Primary | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the... and other conditions

United States
National Cancer Institute (NCI)

Completed

Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery

Adenocarcinoma of the Rectum | Stage I Colon Cancer | Stage I Rectal Cancer | Stage II Colon Cancer | Stage II Rectal Cancer | Stage III Colon Cancer | Stage III Rectal Cancer | Adenocarcinoma of the Colon

United States
Duke University
Wallace H. Coulter Foundation

Completed

Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

Cancer of the Cervix, Cancer of the Endometrium

United States
Memorial Sloan Kettering Cancer Center

Active, not recruiting

Acupuncture Pilot Study for Cancer-related Cognitive Function

Gynecologic Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage III Breast Cancer | Stage III Gynecologic Cancer | Stage III Colorectal Cancer | Stage I Colorectal Cancer | Stage II Colorectal Cancer | Stage I Gynecologic... and other conditions

United States
Mayo Clinic
National Cancer Institute (NCI)

Completed

Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Mucositis | Tongue Cancer | Oral Complications | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Larynx | Recurrent... and other conditions

United States
University of Washington
National Cancer Institute (NCI)

Completed

L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer

Mucositis | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma... and other conditions

United States
University of British Columbia
AstraZeneca; Ozmosis Research Inc.

Recruiting

SCION: SABR and Checkpoint Inhibition Of NSCLC (SCION)

Carcinoma, Non-Small-Cell Lung | Lung Cancer | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Lung Cancer Stage I | Lung Adenocarcinoma, Stage I | Lung Squamous Cell Carcinoma Stage I

Canada

Clinical Trials on Standard surgical procedure for endometrial cancer

University of Bologna

Recruiting

Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer (COVID-CRC)

Colorectal Neoplasms Malignant

Italy
ARNAS Civico Di Cristina Benfratelli Hospital

Not yet recruiting

a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)

Endometrial Cancer

Italy
University of Campania "Luigi Vanvitelli"

Recruiting

Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study

Inflammatory Response | Endometrial Neoplasms

Italy
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Completed

Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer

Endometrial Cancer | Extreme Obesity

Turkey
South Valley University

Completed

Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival

Cancer, Rectum

Egypt
Radboud University Medical Center
Stichting Katholieke Universiteit

Completed

Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients (DECENDO)

Endometrial Cancer

Netherlands
China Medical University Hospital

Recruiting

Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients

Breast Cancer | Colorectal Cancer | Cancer of Ovary | Cancer of Endometrium

Taiwan
University of Florida

Recruiting

Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries

Flexor Tendon

United States
Western Galilee Hospital-Nahariya

Completed

The Difference in Preoperative Evaluation That is Given by a Senior Physician, a Specialist, and a Computer Program (ACS)

Surgery
Assiut University

Recruiting

Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer

Endometrial Cancer

Egypt

Endometrial Cancer Lymphadenectomy Trial (ECLAT)

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Cancer of Endometrium Stage I

Clinical Trials on Standard surgical procedure for endometrial cancer

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