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Lymphadenectomy In Ovarian Neoplasms (LION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00712218
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Ursula Ghulami, Philipps University Marburg Medical Center

Study Description
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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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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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, ].


Outcome Measures
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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). ]

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

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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Philipps University Marburg Medical Center
German Research Foundation
Investigators
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Principal Investigator: Uwe Wagner, MD, Prof University Marburg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ursula Ghulami, KKS Marburg sponsor representative, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00712218    
Other Study ID Numbers: AGO-OVAR OP.3
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Keywords provided by Ursula Ghulami, Philipps University Marburg Medical Center:
Ovarian cancer, FIGO stage IIB-IV
Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders