Lymphadenectomy In Ovarian Neoplasms

Not Applicable

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00712218
• Lead Sponsor: Philipps University Marburg Medical Center

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 available

Study Timeline

• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Study Start: 2008-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 640

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Survival	time from randomization until death

Secondary Outcome Measures

Name	Time	Method
- Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes	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).

Trial Locations

Locations (58)

Universitaetsklinik Graz; 🇦🇹 Graz, Austria

Universitaetskliniken LKH Innsbruck; 🇦🇹 Innsbruck, Austria

Klinikum Wels-Grieskirchen; 🇦🇹 Wels, Austria

AKH Wien; 🇦🇹 Wien, Austria

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Odd G1, gyn. por. klinika VFN; 🇨🇿 Praha, Czechia

Ostalb Klinikum Aalen; 🇩🇪 Aalen, Germany

Klinikum Ansbach; 🇩🇪 Ansbach, Germany

Hochtaunus-Kliniken gGmbH; 🇩🇪 Bad Homburg, Germany

SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus; 🇩🇪 Berlin, Germany

Scroll for more (48 remaining)