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Lymphadenectomy In Ovarian Neoplasms (LION)

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ClinicalTrials.gov Identifier: NCT00712218
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Ursula Ghulami, Philipps University Marburg Medical Center

Brief Summary:

To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.

Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives


Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: No Lymphadenectomy (LNE) Procedure: Lymphadenectomy (LNE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
Study Start Date : December 2008
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Active Comparator: A Procedure: No Lymphadenectomy (LNE)
No lymphadenectomy is performed in patients of the control group

Experimental: B Procedure: 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, ].




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: time from randomization until death ]

Secondary Outcome Measures :
  1. - Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes [ Time Frame: Progression-free survival time is calculated from the date of surgery until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation). ]


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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:

  • Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)
  • 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:

  • Non epithelial ovarian malignancies and borderline tumors
  • 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

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): NCT00712218


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Locations
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Austria
Universitaetsklinik Graz
Graz, Austria, 8036
Universitaetskliniken LKH Innsbruck
Innsbruck, Austria, 6020
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
AKH Wien
Wien, Austria, 1090
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
Czechia
Odd G1, gyn. por. klinika VFN
Praha, Czechia, 12808
Germany
Ostalb Klinikum Aalen
Aalen, Germany, 73430
Klinikum Ansbach
Ansbach, Germany, 91522
Hochtaunus-Kliniken gGmbH
Bad Homburg, Germany, 61348
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
Berlin, Germany, 10365
Charite Campus Virchow-Klinikum
Berlin, Germany, 13353
Universitaetsklinikum Bonn
Bonn, Germany, 53105
Malteser Krankenhaus Bonn-Rhein/Sieg
Bonn, Germany, 53123
Klinikum Bremen
Bremen, Germany, 28177
Klinikum des Landkreises Deggendorf
Deggendorf, Germany, 94469
Donau-Ries Klinik Donauwoerth
Donauwoerth, Germany, 86609
Universitaetsklinikum Carl Gustac Carus
Dresden, Germany, 01304
Evangelisches Krankenhaus
Duesseldorf, Germany, 40217
Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus
Duesseldorf, Germany, 40489
Universitaetsklinikum Erlangen-Nuernberg
Erlangen, Germany, 91054
Universitaetsklinikum Essen
Essen, Germany, 45122
Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH
Essen, Germany, 45136
Klinikum der Johann-Wolfgang-Goethe Universitaet
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Klinikum Fuerth
Fuerth, Germany, 90766
Klinikum Goettingen
Goettingen, Germany, 37075
Klinikum der Ernst-Moritz-Arndt-Universitaet
Greifswald, Germany, 17485
Universitaetsklikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Albertinen Krankenhaus
Hamburg, Germany, 22457
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitaetsklinikum Jena
Jena, Germany, 07743
Universitaetsklinikum Schleswig Holstein, Campus Kiel
Kiel, Germany, 54105
Universitaetsklinik Koeln
Koeln, Germany, 50931
Asklepios Klinik
Lich, Germany, 35423
Klinikum Lueneburg
Lueneburg, Germany, 21339
Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
Marburg, Germany, 35033
Klinikum der Universität Muenchen-Grosshadern
Muenchen, Germany, 81377
Klinikum rechts der Isar
Muenchen, Germany, 81675
Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt
Neumarkt i. d. Opf, Germany, 92318
Klinikum Offenbach
Offenbach, Germany, 63069
Ortenau Klinikum St. Josefsklinik
Offenburg, Germany, 77654
Oberschwabenklinik Krankenhaus St. Elisabeth
Ravensburg, Germany, 88212
Caritas-Krankenhaus St. Josef
Regensburg, Germany, 93053
Frauenklinik Sana-Klinikum Remscheid GmbH
Remscheid, Germany, 42859
Staedtisches Klinikum Solingen
Solingen, Germany, 42653
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Universitaetsklinikum Ulm
Ulm, Germany, 89075
Dr. Horst-Schmidt-Klinik
Wiesbaden, Germany, 65199
Klinikum der Stadt Wolfsburg
Wolfsburg, Germany, 38440
Italy
Centro di Riferimento Oncologico
Aviano, Italy, 33081
Università Cattolica del Sacro Cuore
Campobasso, Italy, 86100
Ospedale di Carpi
Carpi, Italy, 41012
Fondazione IRCCS
Milano, Italy, 20133
IEO - European Institue of Oncology (Instituto Europeo di Oncologia)
Milano, Italy, 20141
Azienda Ospedaliera S. Gerardo di Monza
Monza, Italy, 20052
National Cancer Institute Naples
Naples, Italy, 80131
Università Cattolica del Sacro Cuore
Rome, Italy, 00168
Ospedale Mauriziano Torino
Torino, Italy, 10128
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-74
Sponsors and Collaborators
Philipps University Marburg Medical Center
German Research Foundation
Investigators
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Principal Investigator: Uwe Wagner, MD, Prof University Marburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ursula Ghulami, KKS Marburg sponsor representative, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00712218     History of Changes
Other Study ID Numbers: AGO-OVAR OP.3
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Ursula Ghulami, Philipps University Marburg Medical Center:
Ovarian cancer, FIGO stage IIB-IV

Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type