Lymphadenectomy In Ovarian Neoplasms - Full Text View

Lymphadenectomy In Ovarian Neoplasms (LION)

This study is not yet open for participant recruitment.

Verified by Philipps University Marburg Medical Center, July 2008

Sponsors and Collaborators:	Philipps University Marburg Medical Center Deutsche Forschungsgemeinschaft
Information provided by:	Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:	NCT00712218

Purpose

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

Condition	Intervention
Ovarian Cancer	Procedure: No Lymphadenectomy (LNE) Procedure: Lymphadenectomy (LNE)

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Interventional
Official Title:	Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:

Overall Survival [ Time Frame: time from randomization until death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

- 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). ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
A: Active Comparator	Procedure: No Lymphadenectomy (LNE)
B: Experimental	Procedure: Lymphadenectomy (LNE)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712218

Locations

Germany
Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie
Marburg, Germany, 35033

Sponsors and Collaborators

Philipps University Marburg Medical Center

Deutsche Forschungsgemeinschaft

More Information

Responsible Party:	Coordinating Centre for Clinical Trials, Philipps-University Marburg ( Schade-Brittinger )
Study ID Numbers:	AGO-OVAR OP.3
Study First Received:	July 3, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712218
Health Authority:	Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:

Patients with advanced

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009