Lymphadenectomy In Ovarian Neoplasms (LION)
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|ClinicalTrials.gov Identifier: NCT00712218|
Recruitment Status : Unknown
Verified February 2012 by Carmen Schade-Brittinger, Philipps University Marburg Medical Center.
Recruitment status was: Active, not recruiting
First Posted : July 9, 2008
Last Update Posted : February 2, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Procedure: No Lymphadenectomy (LNE) Procedure: Lymphadenectomy (LNE)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|Active Comparator: A||
Procedure: No Lymphadenectomy (LNE)
No lymphadenectomy is performed in patients of the control group
Procedure: 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, ].
- Overall Survival [ Time Frame: time from randomization until death ]
- - 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). ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712218
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|Principal Investigator:||Uwe Wagner, MD, Prof||University Marburg|