Spots Global Cancer Trial Database for Lymphadenectomy in Early Ovarian Cancer

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Trial Identification

Brief Title: Lymphadenectomy in Early Ovarian Cancer

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

Study ID: NCT04710797

Conditions

Ovarian Cancer

Lymphadenectomy

Interventions

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Comprehensive staging surgery with no Lymphadenectomy

Study Description

Brief 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.

Detailed Description: 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.