NCT00712218

Lymphadenectomy In Ovarian Neoplasms

Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
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 \[24, \].

Timeline

• Start date: 2008-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2008-07-09
• Last updated: 2020-03-04

Locations

59 sites across 6 countries: Austria, Belgium, Czechia, Germany, Italy, South Korea