Clinical trial · Interventional
Lymphadenectomy In Ovarian Neoplasms
Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
NCT00712218CI-TRIAL-00043810LIONcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphadenectomy (LNE) | Procedure | — | UNRESOLVED |
| No Lymphadenectomy (LNE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- interventionNames
- Procedure: No Lymphadenectomy (LNE)
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Procedure: Lymphadenectomy (LNE)
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- time from randomization until death
Secondary outcomes (1)
- measure
- - Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHarter 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. PMID 30811909