LOVEA Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
+ Comprehensive staging surgery with no Lymphadenectomy
Urogenital Diseases+12
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: January 31, 2021
Actual date on which the first participant was enrolled.OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy. OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months. PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.656 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, ChinaOpen Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center in Google Maps