Lymphadenectomy In Ovarian Neoplasms (LION)

• ClinicalTrials.gov Identifier: NCT00712218
• Recruitment Status: Completed
• First Posted: July 9, 2008
• Last Update Posted: March 4, 2020
• Sponsor: Philipps University Marburg Medical Center
• Collaborator: German Research Foundation
• Information provided by (Responsible Party): Ursula Ghulami, Philipps University Marburg Medical Center

Tracking Information

• First Submitted Date: July 3, 2008
• First Posted Date: July 9, 2008
• Last Update Posted Date: March 4, 2020
• Study Start Date: December 2008
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 8, 2008): Overall Survival [ Time Frame: time from randomization until death ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 8, 2008): - 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). ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lymphadenectomy In Ovarian Neoplasms
• Official Title: Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer

Intervention

• 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, ].

Study Arms

• Active Comparator: A
  Intervention: Procedure: No Lymphadenectomy (LNE)
• Experimental: B
  Intervention: Procedure: Lymphadenectomy (LNE)

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 1, 2011): 640
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Czechia, Germany, Italy, Korea, Republic of
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT00712218
• Other Study ID Numbers: AGO-OVAR OP.3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ursula Ghulami, Philipps University Marburg Medical Center
• Original Responsible Party: Schade-Brittinger, Coordinating Centre for Clinical Trials, Philipps-University Marburg
• Current Study Sponsor: Philipps University Marburg Medical Center
• Original Study Sponsor: Same as current
• Collaborators: German Research Foundation

Investigators

• Principal Investigator: Uwe Wagner, MD, Prof; University Marburg

• PRS Account: Philipps University Marburg Medical Center
• Verification Date: March 2020