RecruitingNot ApplicableNCT04710797

Lymphadenectomy in Early Ovarian Cancer

A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer


Sponsor

Sun Yat-sen University

Enrollment

656 participants

Start Date

Jan 31, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether lymph node removal (lymphadenectomy) improves survival and reduces recurrence in women with early-stage epithelial ovarian cancer who need follow-up chemotherapy after surgery. Early ovarian cancer is curable in many cases, and this study aims to clarify the role of lymph node surgery. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with early-stage epithelial ovarian cancer (FIGO stage IA-IIA) that requires chemotherapy - Your specific cancer type is high-grade serous, grade 3 endometrioid, clear cell, or certain other subtypes with specific features - You either have not had prior treatment or had incomplete initial surgery **You may NOT be eligible if...** - Your cancer does not meet the specific stage and type criteria - You are not a candidate for surgery - You have had complete staging surgery already - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURECompletion staging surgery including systematic pelvic and para-aortic lymphadenectomy

* 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

PROCEDUREComprehensive staging surgery with no Lymphadenectomy

* 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 * In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes


Locations(1)

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04710797


Related Trials