Lymphadenectomy In Ovarian Neoplasms

Study Overview
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Brief Summary
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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

Official Title
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Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: No Lymphadenectomy (LNE)
* Procedure: Lymphadenectomy (LNE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Procedure: No Lymphadenectomy (LNE)<br>* No lymphadenectomy is performed in patients of the control group<br>|
| Experimental: B<br> | Procedure: Lymphadenectomy (LNE)<br>* 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, ].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | time from randomization until death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, FIGO stage IIB-IV