This trial is active, not recruiting.

Condition ovarian cancer
Treatments no lymphadenectomy (lne), lymphadenectomy (lne)
Phase phase 3
Sponsor Carmen Schade-Brittinger
Collaborator German Research Foundation
Start date December 2008
End date December 2017
Trial size 640 participants
Trial identifier NCT00712218, AGO-OVAR OP.3


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
no lymphadenectomy (lne)
No lymphadenectomy is performed in patients of the control group
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, ].

Primary Outcomes

Overall Survival
time frame: time from randomization until death

Secondary Outcomes

- 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

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
Principal investigator Uwe Wagner, MD, Prof
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Philipps University Marburg Medical Center.