Lymphadenectomy In Ovarian Neoplasms
- Conditions
- Ovarian Cancer
- Interventions
- Procedure: No Lymphadenectomy (LNE)Procedure: Lymphadenectomy (LNE)
- Registration Number
- NCT00712218
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 640
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A No Lymphadenectomy (LNE) - B Lymphadenectomy (LNE) -
- Primary Outcome Measures
Name Time Method Overall Survival time from randomization until death
- Secondary Outcome Measures
Name Time Method - 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).
Trial Locations
- Locations (58)
Universitaetskliniken LKH Innsbruck
🇦🇹Innsbruck, Austria
Hochtaunus-Kliniken gGmbH
🇩🇪Bad Homburg, Germany
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Erlangen-Nuernberg
🇩🇪Erlangen, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Albertinen Krankenhaus
🇩🇪Hamburg, Germany
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
AKH Wien
🇦🇹Wien, Austria
Oberschwabenklinik Krankenhaus St. Elisabeth
🇩🇪Ravensburg, Germany
Klinikum Offenbach
🇩🇪Offenbach, Germany
Klinikum der Johann-Wolfgang-Goethe Universitaet
🇩🇪Frankfurt, Germany
Klinikum Goettingen
🇩🇪Göttingen, Germany
Ortenau Klinikum St. Josefsklinik
🇩🇪Offenburg, Germany
Ostalb Klinikum Aalen
🇩🇪Aalen, Germany
Universitaetsklinik Graz
🇦🇹Graz, Austria
Klinikum Ansbach
🇩🇪Ansbach, Germany
Odd G1, gyn. por. klinika VFN
🇨🇿Praha, Czechia
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
🇩🇪Berlin, Germany
Malteser Krankenhaus Bonn-Rhein/Sieg
🇩🇪Bonn, Germany
Charite Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Klinikum des Landkreises Deggendorf
🇩🇪Deggendorf, Germany
Klinikum Bremen
🇩🇪Bremen, Germany
Donau-Ries Klinik Donauwoerth
🇩🇪Donauwoerth, Germany
Universitaetsklinikum Carl Gustac Carus
🇩🇪Dresden, Germany
Evangelisches Krankenhaus
🇩🇪Duesseldorf, Germany
Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus
🇩🇪Duesseldorf, Germany
Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH
🇩🇪Essen, Germany
Universitaetsklikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum Fuerth
🇩🇪Fuerth, Germany
Klinikum der Ernst-Moritz-Arndt-Universitaet
🇩🇪Greifswald, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum der Universität Muenchen-Grosshadern
🇩🇪Muenchen, Germany
Asklepios Klinik
🇩🇪Lich, Germany
Universitaetsklinikum Jena
🇩🇪Jena, Germany
Klinikum Lueneburg
🇩🇪Lueneburg, Germany
Universitaetsklinikum Schleswig Holstein, Campus Kiel
🇩🇪Kiel, Germany
Universitaetsklinik Koeln
🇩🇪Koeln, Germany
Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
🇩🇪Marburg, Germany
Klinikum rechts der Isar
🇩🇪Muenchen, Germany
Caritas-Krankenhaus St. Josef
🇩🇪Regensburg, Germany
Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt
🇩🇪Neumarkt i. d. Opf, Germany
Frauenklinik Sana-Klinikum Remscheid GmbH
🇩🇪Remscheid, Germany
Staedtisches Klinikum Solingen
🇩🇪Solingen, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Dr. Horst-Schmidt-Klinik
🇩🇪Wiesbaden, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Klinikum der Stadt Wolfsburg
🇩🇪Wolfsburg, Germany
Università Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Centro di Riferimento Oncologico
🇮🇹Aviano, 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
Ospedale Mauriziano Torino
🇮🇹Torino, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of