Ovarian CancerLIONNCT00712218
Lymphadenectomy In Ovarian Neoplasms
A study testing No Lymphadenectomy (LNE) and Lymphadenectomy (LNE) in people with Ovarian Cancer, run by Philipps University Marburg at 59 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- No Lymphadenectomy (LNE) and Lymphadenectomy (LNE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 59 sitesin 6 countries
- Study dates
- Dec 2008to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
59 sites in 6 countries.
59 sites in 6 countries
Germany43 sites
Ostalb Klinikum Aalen
Aalen, 73430
Klinikum Ansbach
Ansbach, 91522
Hochtaunus-Kliniken gGmbH
Bad Homburg, 61348
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
Berlin, 10365
Charite Campus Virchow-Klinikum
Berlin, 13353
Universitaetsklinikum Bonn
Bonn, 53105
Malteser Krankenhaus Bonn-Rhein/Sieg
Bonn, 53123
Klinikum Bremen
Bremen, 28177
Universitaetsklinik Koeln
Cologne, 50931
Klinikum des Landkreises Deggendorf
Deggendorf, 94469
Donau-Ries Klinik Donauwoerth
Donauwörth, 86609
Universitaetsklinikum Carl Gustac Carus
Dresden, 01304
Evangelisches Krankenhaus
Düsseldorf, 40217
Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus
Düsseldorf, 40489
Universitaetsklinikum Erlangen-Nuernberg
Erlangen, 91054
Universitaetsklinikum Essen
Essen, 45122
Kliniken Essen Mitte - Evang. Huyssens Stiftung/Knappschaft GmbH
Essen, 45136
Klinikum der Johann-Wolfgang-Goethe Universitaet
Frankfurt, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Klinikum Fuerth
Fürth, 90766
Klinikum Goettingen
Göttingen, 37075
Klinikum der Ernst-Moritz-Arndt-Universitaet
Greifswald, 17485
Universitaetsklikum Hamburg-Eppendorf
Hamburg, 20246
Albertinen Krankenhaus
Hamburg, 22457
Medizinische Hochschule Hannover
Hanover, 30625
Universitaetsklinikum Jena
Jena, 07743
Universitaetsklinikum Schleswig Holstein, Campus Kiel
Kiel, 54105
Asklepios Klinik
Lich, 35423
Klinikum Lueneburg
Lüneburg, 21339
Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
Marburg, 35033
Klinikum der Universität Muenchen-Grosshadern
München, 81377
Klinikum rechts der Isar
München, 81675
Kliniken des Landkreises Neumarkt i. d. Opf, Klinikum Neumarkt
Neumarkt I. D. Opf, 92318
Klinikum Offenbach
Offenbach, 63069
Ortenau Klinikum St. Josefsklinik
Offenburg, 77654
Oberschwabenklinik Krankenhaus St. Elisabeth
Ravensburg, 88212
Caritas-Krankenhaus St. Josef
Regensburg, 93053
Frauenklinik Sana-Klinikum Remscheid GmbH
Remscheid, 42859
Staedtisches Klinikum Solingen
Solingen, 42653
Universitätsklinikum Tübingen
Tübingen, 72076
Universitaetsklinikum Ulm
Ulm, 89075
Dr. Horst-Schmidt-Klinik
Wiesbaden, 65199
Klinikum der Stadt Wolfsburg
Wolfsburg, 38440
Italy9 sites
Centro di Riferimento Oncologico
Aviano, 33081
Università Cattolica del Sacro Cuore
Campobasso, 86100
Ospedale di Carpi
Carpi, 41012
Fondazione IRCCS
Milan, 20133
IEO - European Institue of Oncology (Instituto Europeo di Oncologia)
Milan, 20141
Azienda Ospedaliera S. Gerardo di Monza
Monza, 20052
National Cancer Institute Naples
Naples, 80131
Università Cattolica del Sacro Cuore
Rome, 00168
Ospedale Mauriziano Torino
Torino, 10128
Austria4 sites
Universitaetsklinik Graz
Graz, 8036
Universitaetskliniken LKH Innsbruck
Innsbruck, 6020
AKH Wien
Vienna, 1090
Klinikum Wels-Grieskirchen
Wels, 4600
About this study
Official title: 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
- Conditions
- Ovarian Cancer
- Being tested
- No Lymphadenectomy (LNE), Lymphadenectomy (LNE)
- Keywords
- Ovarian cancer, FIGO stage IIB-IV
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Lymphadenectomy (LNE)Procedure or surgery
No lymphadenectomy is performed in patients of the control group
Lymphadenectomy (LNE)Procedure or surgery
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, ].
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Procedure: No Lymphadenectomy (LNE) |
| B | Experimental | Not described Receives: Procedure: Lymphadenectomy (LNE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: time from randomization until death
Secondary outcomes (1)
- Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Ursula Ghulami, Philipps University Marburg
- Investigators
- Uwe Wagner, MD, Prof, Principal investigator, University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712218
- Sponsor's protocol ID
- AGO-OVAR OP.3
- Acronym
- LION
- Status last verified
- Mar 2020
- First submitted
- 3 Jul 2008
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30811909
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
- ClinicalTrials.gov ID
- NCT00712218
- Acronym / sponsor ID
- LION / AGO-OVAR OP.3
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, FIGO stage IIB-IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Dec 2008
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: No Lymphadenectomy (LNE) |
| B | Experimental | Procedure: Lymphadenectomy (LNE) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Lymphadenectomy (LNE)No lymphadenectomy is performed in patients of the control group | Procedure or surgery | A |
| 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, ]. | Procedure or surgery | B |
Primary outcome
Overall Survival
Time frame: time from randomization until death
1 secondary outcome
- 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 30811909Harter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Wagner, MD, Prof principal investigator
University Marburg
59 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Lymphadenectomy (LNE) and Lymphadenectomy (LNE) in people with Ovarian Cancer, run by Philipps University Marburg at 59 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Germany, Italy, Austria, Belgium, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: time from randomization until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.