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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
German Research Foundation
Information provided by (Responsible Party):
Carmen Schade-Brittinger, 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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Procedure: No Lymphadenectomy (LNE)
No lymphadenectomy is performed in patients of the control group
Experimental: B 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, ].

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: time from randomization until death ]

Secondary Outcome Measures :
  1. - 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). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712218

  Show 59 Study Locations
Sponsors and Collaborators
Carmen Schade-Brittinger
German Research Foundation
Principal Investigator: Uwe Wagner, MD, Prof University Marburg

Responsible Party: Carmen Schade-Brittinger, Philipps University Marburg, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00712218     History of Changes
Other Study ID Numbers: AGO-OVAR OP.3
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Carmen Schade-Brittinger, Philipps University Marburg Medical Center:
Ovarian cancer, FIGO stage IIB-IV

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders