Lymphadenectomy in Early Ovarian Cancer | NCT04710797

NCT04710797

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Lymphadenectomy	Experimental	Comprehensive staging surgery with no Lymphadenectomy	Procedure: Comprehensive staging surgery with no Lymphadenectomy
Lymphadenectomy	Active Comparator	Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy	Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy	Procedure	open or minimally invasive surgical approach cytologic examinations All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied BSO and hysterectomy For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered Omentectomy Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS(Progression-free survival)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes

Measure	Description	Time Frame
OS(Overall Survival)	From date of randomization until the date of death from any cause or date of last follow up, whichever came first	From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
Recurrence rate of lymph node

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Jihong Liu, Ph.D.	Contact	86-20-87343102		liujih@mail.sysu.edu.cn
Ting Deng, Ph.D.	Contact	86-20-87343105		dengting@sysucc.org.cn

Name	Affiliation	Role
Jihong Liu, Ph.D.	Sun Yat-sen University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510060	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37116952	Derived	Deng T, Liu K, Chen L, Chen X, Li HW, Guo H, Zhang H, Xiang L, Feng X, Wang X, Ngan HY, Zhao J, Zou D, Liu Q, Liu J. A prospective randomized multicenter trial for lymphadenectomy in early-stage ovarian cancer: LOVE study. J Gynecol Oncol. 2023 May;34(3):e52. doi: 10.3802/jgo.2023.34.e52. Epub 2023 Apr 10.