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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
No lymphadenectomy is performed in patients of the control group
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 \[24, \].
Overall Survival
Time frame: time from randomization until death
- 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitaetsklinik Graz
Graz, Austria
Universitaetskliniken LKH Innsbruck
Innsbruck, Austria
AKH Wien
Vienna, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
UZ Gasthuisberg
Leuven, Belgium
Odd G1, gyn. por. klinika VFN
Prague, Czechia
Ostalb Klinikum Aalen
Aalen, Germany
Klinikum Ansbach
Ansbach, Germany
Hochtaunus-Kliniken gGmbH
Bad Homburg, Germany
SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus
Berlin, Germany
...and 49 more locations