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Endometrial Cancer Lymphadenectomy Trial (ECLAT)

Primary Purpose

Cancer of Endometrium Stage I, Cancer of Endometrium Stage II

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard surgical procedure for endometrial cancer
systematic lymphadenectomy (LNE)
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Endometrium Stage I

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Ostalb-Klinikum Aalen, FrauenklinikRecruiting
  • Klinikum St. Marien Amberg, FrauenklinikRecruiting
  • Klinikum Ansbach, Klinikum AnsbachRecruiting
  • Universitätsklinikum Augsburg, FrauenklinikRecruiting
  • Hochtaunus-Kliniken gGmbH, FrauenklinikRecruiting
  • Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für FrauenheilkundeRecruiting
  • SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, FrauenklinikRecruiting
  • Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und GeburtsmedizinRecruiting
  • Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und GeburtshilfeRecruiting
  • Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und GeburtsmedizinRecruiting
  • Martin-Luther-Krankenhaus, Klinik für Gynäkologie und GeburtshilfeRecruiting
  • Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. FrauenheilkundeRecruiting
  • Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und GeburtshilfeRecruiting
  • Städtisches Klinikum Braunschweig gGmbH, FrauenklinikRecruiting
  • Klinikum Bremen Mitte gGmbH, FrauenklinikRecruiting
  • Kliniken Böblingen, FrauenklinikRecruiting
  • Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. GeburtshilfeRecruiting
  • Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. GeburtshilfeRecruiting
  • Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische OnkologieRecruiting
  • Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und GeburtshilfeRecruiting
  • Universitätsklinikum Freiburg, UniversitätsfrauenklinikRecruiting
  • Klinikum Fulda gAG, FrauenklinikRecruiting
  • Klinikum Fürth, Frauenklinik NathanstiftRecruiting
  • Universitätsklinikum Gießen und Marburg GmbH, FrauenklinikRecruiting
  • Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
  • Klinikum Göttingen, Georg-August-Universität, UniversitätsfrauenklinikRecruiting
  • Klinikum Gütersloh, FrauenklinikRecruiting
  • Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für GynäkologieRecruiting
  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für GynäkologieRecruiting
  • Agaplesion Diakonieklinikum Hamburg, FrauenklinikRecruiting
  • Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 GynäkologieRecruiting
  • Medizinische Hochschule Hannover, FrauenklinikRecruiting
  • Universitätsklinikum Jena, Klinik für Frauenheilkunde und GeburtshilfeRecruiting
  • Städtisches Klinikum Karlsruhe, FrauenklinikRecruiting
  • ViDia Christliche Kliniken Karlsruhe, FrauenklinikRecruiting
  • Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und GeburtshilfeRecruiting
  • Klinikum Mannheim GmbH, Universitäts-FrauenklinikRecruiting
  • Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und GeburtshilfeRecruiting
  • Klinikum Dritter Orden, Klinik für Gynäkologie und GeburtshilfeRecruiting
  • Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und GeburtshilfeRecruiting
  • Klinikum rechts der Isar der Technischen Universität, Frauen- und PoliklinikRecruiting
  • Klinikum Offenbach GmbH, FrauenklinikRecruiting
  • Ortenau Klinikum St. Josefsklinik, GynäkologieRecruiting
  • Klinikum Passau, FrauenklinikRecruiting
  • Oberschwabenklinik Krankenhaus St. Elisabeth, FrauenklinikRecruiting
  • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. GeburtshilfeRecruiting
  • Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und GeburtshilfeRecruiting
  • Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. GeburtshilfeRecruiting
  • Klinikum Starnberg, Klinik für Frauenheilkunde und GeburtshilfeRecruiting
  • Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und GeburtshilfeRecruiting
  • Kreiskliniken Traunstein-Trostberg GmbH, FrauenklinikRecruiting
  • Universitätsklinikum Tübingen, UniversitätsfrauenklinikRecruiting
  • Universitätsklinikum Ulm, UniversitätsfrauenklinikRecruiting
  • Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und GeburtshilfeRecruiting
  • Schwarzwald-Baar Klinikum, FrauenklinikRecruiting
  • St. Josefs-Hospital, FrauenklinikRecruiting
  • Klinikum der Stadt Wolfsburg, FrauenklinikRecruiting
  • Okayama University HospitalRecruiting
  • Saitama Medical University International Medical CenterRecruiting
  • Seoul National University Hospital, Department of Obstetrics & GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A standard surgical procedure

Arm B systematic lymphadenectomy (LNE)

Arm Description

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

In addition to standard procedures as defined for Arm A: systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease free survival (DFS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival
Disease specific survival (DSS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival
Assessment of serious complications
Assessment of perioperative complications and site effects of LNE
EORTC QLQ-C30
Health related Quality of life (QoL)
EORTC QLQ-EN24
Health related Quality of life (QoL)
Number of resected lymph nodes
resected pelvic and para-aortic lymph nodes

Full Information

First Posted
January 31, 2018
Last Updated
May 9, 2023
Sponsor
Philipps University Marburg Medical Center
Collaborators
German Cancer Aid
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1. Study Identification

Unique Protocol Identification Number
NCT03438474
Brief Title
Endometrial Cancer Lymphadenectomy Trial
Acronym
ECLAT
Official Title
Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
February 15, 2028 (Anticipated)
Study Completion Date
February 15, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
German Cancer Aid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Endometrium Stage I, Cancer of Endometrium Stage II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A standard surgical procedure
Arm Type
Active Comparator
Arm Description
Standard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
Arm Title
Arm B systematic lymphadenectomy (LNE)
Arm Type
Experimental
Arm Description
In addition to standard procedures as defined for Arm A: systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Intervention Type
Procedure
Intervention Name(s)
Standard surgical procedure for endometrial cancer
Intervention Description
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
Intervention Type
Procedure
Intervention Name(s)
systematic lymphadenectomy (LNE)
Intervention Description
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival
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
Title
Disease specific survival (DSS)
Description
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival
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
Title
Assessment of serious complications
Description
Assessment of perioperative complications and site effects of LNE
Time Frame
during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
Title
EORTC QLQ-C30
Description
Health related Quality of life (QoL)
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
Title
EORTC QLQ-EN24
Description
Health related Quality of life (QoL)
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
Title
Number of resected lymph nodes
Description
resected pelvic and para-aortic lymph nodes
Time Frame
during surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Günter Emons, Professor MD
Phone
0049 (0) 551-39 66532
Email
emons@med.uni-goettingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Harter, MD
Phone
0049 (0) 201 1743-4511
Email
p.harter@kliniken-essen-mitte.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Harter, MD
Organizational Affiliation
Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ostalb-Klinikum Aalen, Frauenklinik
City
Aalen
ZIP/Postal Code
73430
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Gnauert, MD
Phone
0049 (0) 7361-551401
Email
karsten.gnauert@kliniken-ostalb.de
Facility Name
Klinikum St. Marien Amberg, Frauenklinik
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Papathemelis, MD
Phone
0049 (0) 9621-381381
Email
papathemelis.thomas@klinikum-amberg.de
Facility Name
Klinikum Ansbach, Klinikum Ansbach
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Koch, MD
Phone
0049 (0) 981-484 2256
Email
martin.koch@anregiomed.de
Facility Name
Universitätsklinikum Augsburg, Frauenklinik
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Dannecker, Professor MD
Phone
0049 (0) 821-400-2331
Email
christian.dannecker@med.uni-augsburg.de
Facility Name
Hochtaunus-Kliniken gGmbH, Frauenklinik
City
Bad Homburg
ZIP/Postal Code
61325
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Denschlag, Professor MD
Phone
0049 (0) 6172 142 580
Email
dominik.denschlag@hochtaunus-kliniken.de
Facility Name
Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Martin Enzinger, MD
Phone
0049 (0) 951-503 15730
Email
hans-martin.enzinger@sozialstiftung-bamberg.de
Facility Name
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens-Peter Scharf, MD
Phone
0049 (0) 30-55182411
Email
j.scharf@sana-kl.de
Facility Name
Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Mangler, MD
Phone
0049 (0) 30-130202402
Email
mandy.mangler@vivantes.de
Facility Name
Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Zelal Muallem, MD
Phone
0049 (0) 30-450 664373
Email
mustafa-zelal.muallem@charite.de
Facility Name
Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaher Halwani, MD
Phone
0049 (0) 30-130121261
Email
zaher.halwani@vivantes.de
Facility Name
Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe
City
Berlin
ZIP/Postal Code
14193
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uwe Ulrich, Professor MD
Phone
0049 (0) 30-8955 83311
Email
u.ulrich@mlk-berlin.de
Facility Name
Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Egger, MD
Phone
0049 (0) 228-287 15447
Email
eva-katharina.egger@ukb.uni-bonn.de
Facility Name
Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe
City
Borna
ZIP/Postal Code
04552
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Einenkel, MD
Phone
0049 (0) 3433 21-1400
Email
jens.einenkel@sana.de
Facility Name
Städtisches Klinikum Braunschweig gGmbH, Frauenklinik
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heiko Franz, MD
Phone
0049 (0) 531-595 3260
Email
h.franz@klinikum-braunschweig.de
Facility Name
Klinikum Bremen Mitte gGmbH, Frauenklinik
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Aydogdu, MD
Phone
0049 (0) 421-497 5351
Email
mustafa.aydogdu@klinikum-bremen-mitte.de
Facility Name
Kliniken Böblingen, Frauenklinik
City
Böblingen
ZIP/Postal Code
71032
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Renner, Professor MD
Phone
0049 (0) 7031-668-22201
Email
S.Renner@klinikverbund-suedwest.de
Facility Name
Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe
City
Donauwörth
ZIP/Postal Code
86609
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe
City
Dresden
ZIP/Postal Code
01304
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Wimberger, Professor MD
Phone
0049 (0) 351-458 16728
Email
pauline.wimberger@uniklinikum-dresden.de
Facility Name
Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe
City
Düsseldorf
ZIP/Postal Code
40489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Lampe, Professor MD
Phone
0049 (0) 211-409 2519
Email
lampe@kaiserswerther-diakonie.de
Facility Name
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Harter, MD
Phone
0049 (0) 201-1743-4511
Email
p.harter@kliniken-essen-mitte.de
Facility Name
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El-Balat, MD
Phone
0049 (0) 69 6301 7438
Email
ahmed.el-balat@kgu.de
Facility Name
Universitätsklinikum Freiburg, Universitätsfrauenklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximilian Klar, MD
Phone
0049 (0) 761-270 30010
Email
maximilian.klar@uniklinik-freiburg.de
Facility Name
Klinikum Fulda gAG, Frauenklinik
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hawighorst, MD
Phone
0049 (0) 661-84 5901
Email
Thomas.Hawighorst@klinikum-fulda.de
Facility Name
Klinikum Fürth, Frauenklinik Nathanstift
City
Fürth
ZIP/Postal Code
90766
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Hanf, Professor MD
Phone
0049 (0) 911-7580 1301
Email
volker.hanf@klinikum-fuerth.de
Facility Name
Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivo Meinhold-Heerlein, Professor MD
Phone
0049 (0) 641-985-45100
Email
ivo.meinhold-heerlein@gyn.med.uni-giessen.de
Facility Name
Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerd Bauerschmitz, MD
Phone
0049 (0) 551-39 66582
Email
gerd.bauerschmitz@med.uni-goettingen.de
Facility Name
Klinikum Gütersloh, Frauenklinik
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wencke Ruhwedel, MD
Phone
0049 (0) 5241-832-4102
Email
wencke.ruhwedel@klinikum-guetersloh.de
Facility Name
Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie
City
Halle/Saale
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Papendick, MD
Phone
0049 (0) 345-557 1323
Email
nancy.papendick@uk-halle.de
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Schmalfeldt, Professor MD
Phone
0049 (0) 40-7410 52510
Email
b.schmalfeldt@uke.de
Facility Name
Agaplesion Diakonieklinikum Hamburg, Frauenklinik
City
Hamburg
ZIP/Postal Code
20259
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Lindner, Professor MD
Phone
0049 (0) 40-790 20 2500
Email
christoph.lindner@d-k-h.de
Facility Name
Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uwe Herwig, MD
Phone
0049 (0) 40-5588-6752
Email
uwe.herwig@albertinen.de
Facility Name
Medizinische Hochschule Hannover, Frauenklinik
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hillemanns, Professor MD
Phone
0049 (0) 511-532 6144
Email
hillemanns.peter@mh-hannover.de
Facility Name
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo B. Runnebaum, Professor MD
Phone
0049 (0) 3641-933063
Email
ingo.runnebaum@med.uni-jena.de
Facility Name
Städtisches Klinikum Karlsruhe, Frauenklinik
City
Karlsruhe
ZIP/Postal Code
73133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Müller, Professor MD
Phone
0049 (0) 721-974 2401
Email
andreas.mueller.fk@klinikum-karlsruhe.de
Facility Name
ViDia Christliche Kliniken Karlsruhe, Frauenklinik
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Tomé, MD
Phone
0049 (0) 721-8108 9003
Email
oliver.tome@vincentius-ka.de
Facility Name
Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe
City
Köln
ZIP/Postal Code
51103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Michael Forner, MD
Phone
0049 (0) 221-8289-5485
Email
dirk.forner@evkk.de
Facility Name
Klinikum Mannheim GmbH, Universitäts-Frauenklinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Tuschy, Professor MD
Phone
0049 (0) 621-383-4176
Email
benjamin.tuschy@umm.de
Facility Name
Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darius Salehin, MD
Phone
0049 (0) 2161-981 1105
Email
darius.salehin@mg.johanniter-kliniken.de
Facility Name
Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe
City
München
ZIP/Postal Code
80638
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franz Edler von Koch, MD
Phone
0049 (0)89-17952501
Email
franz.koch@dritter-orden.de
Facility Name
Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Trillsch, MD
Phone
0049 (0) 89-4400-73723
Email
Fabian.Trillsch@med.uni-muenchen.de
Facility Name
Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Bronger, MD
Phone
0049 (0) 89-4140 2433
Email
holger.bronger@mri.tum.de
Facility Name
Klinikum Offenbach GmbH, Frauenklinik
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Kosse, MD
Phone
0049 (0) 69-8405 7312
Email
jens.kosse@sana.de
Facility Name
Ortenau Klinikum St. Josefsklinik, Gynäkologie
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Frank
Phone
0049 (0) 781-472 3503
Email
matthias.frank@og.ortenau-klinikum.de
Facility Name
Klinikum Passau, Frauenklinik
City
Passau
ZIP/Postal Code
94032
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Dengler, MD
Phone
0049 (0) 851-5300 2297
Email
martin.dengler@klinikum-passau.de
Facility Name
Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Gropp-Meier, MD
Phone
0049 (0) 751-87 2447
Email
martina.gropp-meier@oberschwabenklinik.de
Facility Name
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Seitz, MD
Phone
0049 (0) 941-782 3403
Email
sseitz@caritasstjosef.de
Facility Name
Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Weigel, Professor MD
Phone
0049 (0) 9721-720 2132
Email
mweigel@leopoldina.de
Facility Name
Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe
City
Solingen
ZIP/Postal Code
42653
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Hentsch, MD
Phone
0049 (0) 212-547 2371
Email
hentsch@klinikumsolingen.de
Facility Name
Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe
City
Starnberg
ZIP/Postal Code
82319
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Anthuber, Professor MD
Phone
0049 (0) 8151-18 2312
Email
christoph.anthuber@klinikum-starnberg.de
Facility Name
Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten Scholz, MD
Phone
0049 (0) 9421-710 1450
Email
Carsten.Scholz@klinikum-straubing.de
Facility Name
Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Schindlbeck, MD
Phone
0049 (0) 861-705 1231
Email
christian.schindlbeck@kliniken-sob.de
Facility Name
Universitätsklinikum Tübingen, Universitätsfrauenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kommoss, Professor MD
Phone
0049 (0) 7071-29 82211
Email
stefan.kommoss@med.uni-tuebingen.de
Facility Name
Universitätsklinikum Ulm, Universitätsfrauenklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne Schochter, MD
Phone
0049 (0) 731-500 58688
Email
fabienne.schochter@uniklinik-ulm.de
Facility Name
Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe
City
Unna
ZIP/Postal Code
59423
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristin Kühn, MD
Phone
0049 (0) 2303-100 2071
Email
c.kuehn@hospitalverbund.de
Facility Name
Schwarzwald-Baar Klinikum, Frauenklinik
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Seeborg
Phone
0049 (0) 7721-933116
Email
kurt.seeborg@sbk-vs.de
Facility Name
St. Josefs-Hospital, Frauenklinik
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Gabriel, Professor MD
Phone
0049 (0) 611-177 1512
Email
bgabriel@joho.de
Facility Name
Klinikum der Stadt Wolfsburg, Frauenklinik
City
Wolfsburg
ZIP/Postal Code
38440
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Liebrich, MD
Phone
0049 (0) 5361-80 3813
Email
clemens.liebrich@klinikum.wolfsburg.de
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoji Nagao, MD
Facility Name
Saitama Medical University International Medical Center
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yabuno Akira, MD
Facility Name
Seoul National University Hospital, Department of Obstetrics & Gynecology
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Weon Kim, Professor MD
Phone
0082-2-2072-2821
Email
kjwksh@snu.ac.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34226291
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.
Results Reference
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Endometrial Cancer Lymphadenectomy Trial

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