Clinical trial NCT00712218: Lymphadenectomy In Ovarian Neoplasms
Official title: Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: Ovarian cancer, FIGO stage IIB-IV
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2008-07-09
Enrollment: 640
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Overall Survival
timeFrame: time from randomization until death
Secondary outcomes:
measure: - Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes
timeFrame: 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).
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitaetsklinik Graz
city: Innsbruck
country: Austria
facility: Universitaetskliniken LKH Innsbruck
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Wien
country: Austria
facility: AKH Wien
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Praha
country: Czechia
facility: Odd G1, gyn. por. klinika VFN
city: Aalen
country: Germany
facility: Ostalb Klinikum Aalen
city: Ansbach
country: Germany
facility: Klinikum Ansbach
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken gGmbH
city: Berlin
country: Germany
facility: SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Bonn
country: Germany
facility: Malteser Krankenhaus Bonn-Rhein/Sieg
city: Bremen
country: Germany
facility: Klinikum Bremen
city: Deggendorf
country: Germany
facility: Klinikum des Landkreises Deggendorf
city: Donauwoerth
country: Germany
facility: Donau-Ries Klinik Donauwoerth
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustac Carus
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Duesseldorf
country: Germany
facility: Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen-Nuernberg
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Essen
country: Germany
facility: Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universitaet
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Fuerth
country: Germany
facility: Klinikum Fuerth
city: Greifswald
country: Germany
facility: Klinikum der Ernst-Moritz-Arndt-Universitaet
city: Göttingen
country: Germany
facility: Klinikum Goettingen
city: Hamburg
country: Germany
facility: Universitaetsklikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein, Campus Kiel
city: Koeln
country: Germany
facility: Universitaetsklinik Koeln
city: Lich
country: Germany
facility: Asklepios Klinik
city: Lueneburg
country: Germany
facility: Klinikum Lueneburg
city: Marburg
country: Germany
facility: Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
city: Muenchen
country: Germany
facility: Klinikum der Universität Muenchen-Grosshadern
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar
city: Neumarkt i. d. Opf
country: Germany
facility: Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt
city: Offenbach
country: Germany
facility: Klinikum Offenbach
city: Offenburg
country: Germany
facility: Ortenau Klinikum St. Josefsklinik
city: Ravensburg
country: Germany
facility: Oberschwabenklinik Krankenhaus St. Elisabeth
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef
city: Remscheid
country: Germany
facility: Frauenklinik Sana-Klinikum Remscheid GmbH
city: Solingen
country: Germany
facility: Staedtisches Klinikum Solingen
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Klinik
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
city: Campobasso
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Carpi
country: Italy
facility: Ospedale di Carpi
city: Milano
country: Italy
facility: Fondazione IRCCS
city: Milano
country: Italy
facility: IEO - European Institue of Oncology (Instituto Europeo di Oncologia)
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo di Monza
city: Naples
country: Italy
facility: National Cancer Institute Naples
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Torino
country: Italy
facility: Ospedale Mauriziano Torino
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: University Marburg
name: Uwe Wagner, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.