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Lymphadenectomy In Ovarian Neoplasms (LION)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Carmen Schade-Brittinger, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00712218
First received: July 3, 2008
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cancer
 Procedure: No Lymphadenectomy (LNE)
Procedure: Lymphadenectomy (LNE)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: time from randomization until death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - 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). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 640
Study Start Date: December 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, ].

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712218

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

No publications provided

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
Study First Received: July 3, 2008
Last Updated: February 1, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Neoplasms
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

ClinicalTrials.gov processed this record on June 17, 2013