Lymphadenectomy In Ovarian Neoplasms

Ovarian Cancer Clinical Trial

— LION  

Official title:

Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712218
• Other study ID #: AGO-OVAR OP.3
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Est. completion date: December 2017

Study information

• Verified date: March 2020
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• 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, ].

Locations

Country	Name	City	State
Austria	Universitaetsklinik Graz	Graz
Austria	Universitaetskliniken LKH Innsbruck	Innsbruck
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	AKH Wien	Wien
Belgium	UZ Gasthuisberg	Leuven
Czechia	Odd G1, gyn. por. klinika VFN	Praha
Germany	Ostalb Klinikum Aalen	Aalen
Germany	Klinikum Ansbach	Ansbach
Germany	Hochtaunus-Kliniken gGmbH	Bad Homburg
Germany	Charite Campus Virchow-Klinikum	Berlin
Germany	SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus	Berlin
Germany	Malteser Krankenhaus Bonn-Rhein/Sieg	Bonn
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Klinikum Bremen	Bremen
Germany	Klinikum des Landkreises Deggendorf	Deggendorf
Germany	Donau-Ries Klinik Donauwoerth	Donauwoerth
Germany	Universitaetsklinikum Carl Gustac Carus	Dresden
Germany	Evangelisches Krankenhaus	Duesseldorf
Germany	Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus	Duesseldorf
Germany	Universitaetsklinikum Erlangen-Nuernberg	Erlangen
Germany	Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH	Essen
Germany	Universitaetsklinikum Essen	Essen
Germany	Klinikum der Johann-Wolfgang-Goethe Universitaet	Frankfurt
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Klinikum Fuerth	Fuerth
Germany	Klinikum Goettingen	Göttingen
Germany	Klinikum der Ernst-Moritz-Arndt-Universitaet	Greifswald
Germany	Albertinen Krankenhaus	Hamburg
Germany	Universitaetsklikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum Jena	Jena
Germany	Universitaetsklinikum Schleswig Holstein, Campus Kiel	Kiel
Germany	Universitaetsklinik Koeln	Koeln
Germany	Asklepios Klinik	Lich
Germany	Klinikum Lueneburg	Lueneburg
Germany	Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie	Marburg
Germany	Klinikum der Universität Muenchen-Grosshadern	Muenchen
Germany	Klinikum rechts der Isar	Muenchen
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
Italy	Centro di Riferimento Oncologico	Aviano
Italy	Università Cattolica del Sacro Cuore	Campobasso
Italy	Ospedale di Carpi	Carpi
Italy	Fondazione IRCCS	Milano
Italy	IEO - European Institue of Oncology (Instituto Europeo di Oncologia)	Milano
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
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	German Research Foundation

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany,  Italy,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		time from randomization until death
Secondary	- Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes		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).