Status:
COMPLETED
Lymphadenectomy In Ovarian Neoplasms
Lead Sponsor:
Philipps University Marburg
Collaborating Sponsors:
German Research Foundation
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
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, comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00712218
Start Date
December 1 2008
End Date
December 1 2017
Last Update
March 4 2020
Active Locations (59)
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1
Universitaetsklinik Graz
Graz, Austria, 8036
2
Universitaetskliniken LKH Innsbruck
Innsbruck, Austria, 6020
3
AKH Wien
Vienna, Austria, 1090
4
Klinikum Wels-Grieskirchen
Wels, Austria, 4600