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Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

Phase 3
18 Years
75 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

time from randomization until death

Safety Issue:


Principal Investigator

Uwe Wagner, MD, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Marburg


Germany: Ethics Commission

Study ID:




Start Date:

December 2008

Completion Date:

December 2017

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer, FIGO stage IIB-IV
  • Neoplasms
  • Ovarian Neoplasms