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Lymphadenectomy In Ovarian Neoplasms (LION)

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
No Lymphadenectomy (LNE)
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 Ovarian Cancer focused on measuring Ovarian cancer, FIGO stage IIB-IV

Eligibility Criteria

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

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

Sites / Locations

  • Universitaetsklinik Graz
  • Universitaetskliniken LKH Innsbruck
  • Klinikum Wels-Grieskirchen
  • AKH Wien
  • UZ Gasthuisberg
  • Odd G1, gyn. por. klinika VFN
  • Ostalb Klinikum Aalen
  • Klinikum Ansbach
  • Hochtaunus-Kliniken gGmbH
  • SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
  • Charite Campus Virchow-Klinikum
  • Universitaetsklinikum Bonn
  • Malteser Krankenhaus Bonn-Rhein/Sieg
  • Klinikum Bremen
  • Klinikum des Landkreises Deggendorf
  • Donau-Ries Klinik Donauwoerth
  • Universitaetsklinikum Carl Gustac Carus
  • Evangelisches Krankenhaus
  • Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus
  • Universitaetsklinikum Erlangen-Nuernberg
  • Universitaetsklinikum Essen
  • Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH
  • Klinikum der Johann-Wolfgang-Goethe Universitaet
  • Universitätsklinikum Freiburg
  • Klinikum Fuerth
  • Klinikum der Ernst-Moritz-Arndt-Universitaet
  • Klinikum Goettingen
  • Universitaetsklikum Hamburg-Eppendorf
  • Albertinen Krankenhaus
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Jena
  • Universitaetsklinikum Schleswig Holstein, Campus Kiel
  • Universitaetsklinik Koeln
  • Asklepios Klinik
  • Klinikum Lueneburg
  • Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
  • Klinikum der Universität Muenchen-Grosshadern
  • Klinikum rechts der Isar
  • Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt
  • Klinikum Offenbach
  • Ortenau Klinikum St. Josefsklinik
  • Oberschwabenklinik Krankenhaus St. Elisabeth
  • Caritas-Krankenhaus St. Josef
  • Frauenklinik Sana-Klinikum Remscheid GmbH
  • Staedtisches Klinikum Solingen
  • Universitätsklinikum Tübingen
  • Universitaetsklinikum Ulm
  • Dr. Horst-Schmidt-Klinik
  • Klinikum der Stadt Wolfsburg
  • Centro di Riferimento Oncologico
  • Università Cattolica del Sacro Cuore
  • Ospedale di Carpi
  • Fondazione IRCCS
  • IEO - European Institue of Oncology (Instituto Europeo di Oncologia)
  • Azienda Ospedaliera S. Gerardo di Monza
  • National Cancer Institute Naples
  • Università Cattolica del Sacro Cuore
  • Ospedale Mauriziano Torino
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

- Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes

Full Information

First Posted
July 3, 2008
Last Updated
March 3, 2020
Sponsor
Philipps University Marburg Medical Center
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00712218
Brief Title
Lymphadenectomy In Ovarian Neoplasms
Acronym
LION
Official Title
Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer, FIGO stage IIB-IV

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
No Lymphadenectomy (LNE)
Intervention Description
No lymphadenectomy is performed in patients of the control group
Intervention Type
Procedure
Intervention Name(s)
Lymphadenectomy (LNE)
Intervention Description
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 Measure Information:
Title
Overall Survival
Time Frame
time from randomization until death
Secondary Outcome Measure Information:
Title
- 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).

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30811909
Citation
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.
Results Reference
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Lymphadenectomy In Ovarian Neoplasms

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