Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
640 participants
INTERVENTIONAL
2008-12-31
2017-12-31
Brief Summary
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Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
No Lymphadenectomy (LNE)
No lymphadenectomy is performed in patients of the control group
B
Lymphadenectomy (LNE)
Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions \[24, \].
Interventions
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No Lymphadenectomy (LNE)
No lymphadenectomy is performed in patients of the control group
Lymphadenectomy (LNE)
Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions \[24, \].
Eligibility Criteria
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Inclusion Criteria
* Macroscopic complete resection
* Age: 18 - 75 years
* Patients who have given their signed and written informed consent
* Good performance status (ECOG 0/1)
Exclusion Criteria
* Intraoperative clinically suspicious lymph nodes (bulky nodes)
* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
* Recurrent ovarian cancer
* Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
* Diseases of the lymph system (including lymph edema of unknown origin)
* Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)
* Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
* Prior retroperitoneal lymph node dissection (systematic or sampling)
* Pregnancy
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
* Any reasons interfering with regular follow-up
18 Years
75 Years
FEMALE
No
Sponsors
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German Research Foundation
OTHER
Philipps University Marburg
OTHER
Responsible Party
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Ursula Ghulami
KKS Marburg sponsor representative
Principal Investigators
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Uwe Wagner, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
University Marburg
Locations
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Universitaetsklinik Graz
Graz, , Austria
Universitaetskliniken LKH Innsbruck
Innsbruck, , Austria
AKH Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen
Wels, , Austria
UZ Gasthuisberg
Leuven, , Belgium
Odd G1, gyn. por. klinika VFN
Prague, , Czechia
Ostalb Klinikum Aalen
Aalen, , Germany
Klinikum Ansbach
Ansbach, , Germany
Hochtaunus-Kliniken gGmbH
Bad Homburg, , Germany
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
Berlin, , Germany
Charite Campus Virchow-Klinikum
Berlin, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Malteser Krankenhaus Bonn-Rhein/Sieg
Bonn, , Germany
Klinikum Bremen
Bremen, , Germany
Universitaetsklinik Koeln
Cologne, , Germany
Klinikum des Landkreises Deggendorf
Deggendorf, , Germany
Donau-Ries Klinik Donauwoerth
Donauwörth, , Germany
Universitaetsklinikum Carl Gustac Carus
Dresden, , Germany
Evangelisches Krankenhaus
Düsseldorf, , Germany
Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus
Düsseldorf, , Germany
Universitaetsklinikum Erlangen-Nuernberg
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH
Essen, , Germany
Klinikum der Johann-Wolfgang-Goethe Universitaet
Frankfurt, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Klinikum Fuerth
Fürth, , Germany
Klinikum Goettingen
Göttingen, , Germany
Klinikum der Ernst-Moritz-Arndt-Universitaet
Greifswald, , Germany
Universitaetsklikum Hamburg-Eppendorf
Hamburg, , Germany
Albertinen Krankenhaus
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Schleswig Holstein, Campus Kiel
Kiel, , Germany
Asklepios Klinik
Lich, , Germany
Klinikum Lueneburg
Lüneburg, , Germany
Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
Marburg, , Germany
Klinikum der Universität Muenchen-Grosshadern
München, , Germany
Klinikum rechts der Isar
München, , Germany
Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt
Neumarkt I. D. Opf, , Germany
Klinikum Offenbach
Offenbach, , Germany
Ortenau Klinikum St. Josefsklinik
Offenburg, , Germany
Oberschwabenklinik Krankenhaus St. Elisabeth
Ravensburg, , Germany
Caritas-Krankenhaus St. Josef
Regensburg, , Germany
Frauenklinik Sana-Klinikum Remscheid GmbH
Remscheid, , Germany
Staedtisches Klinikum Solingen
Solingen, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Dr. Horst-Schmidt-Klinik
Wiesbaden, , Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Centro di Riferimento Oncologico
Aviano, , Italy
Università Cattolica del Sacro Cuore
Campobasso, , Italy
Ospedale di Carpi
Carpi, , Italy
Fondazione IRCCS
Milan, , Italy
IEO - European Institue of Oncology (Instituto Europeo di Oncologia)
Milan, , Italy
Azienda Ospedaliera S. Gerardo di Monza
Monza, , Italy
National Cancer Institute Naples
Naples, , Italy
Università Cattolica del Sacro Cuore
Rome, , Italy
Ospedale Mauriziano Torino
Torino, , Italy
Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.
Other Identifiers
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AGO-OVAR OP.3
Identifier Type: -
Identifier Source: org_study_id
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