Lymphadenectomy In Ovarian Neoplasms (LION)

March 3, 2020 updated by: Ursula Ghulami, Philipps University Marburg Medical Center

Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

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

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

No

Genders Eligible for Study

Female

Description

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

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)

Arms and Interventions

Participant Group / 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, ].

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: time from randomization until death
time from randomization until death

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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).
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).

Collaborators and Investigators

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

Sponsor

Philipps University Marburg Medical Center

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Uwe Wagner, MD, Prof, University Marburg

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

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

December 1, 2008

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO-OVAR OP.3

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.

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