The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

Overview

This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

Full Title of Study: “The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

Interventions

  • Procedure: TH
    • Total hysterectomy
  • Procedure: TH/BSO
    • Total hysterectomy and bilateral salpingo-oophorectomy
  • Procedure: BPLND
    • bilateral pelvic and para-aortic lymph node dissection

Arms, Groups and Cohorts

  • Experimental: Total Hysterectomy (TH)
    • Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
  • Active Comparator: TH and bilateral salpingo-oophorectomy (TH/BSO)
    • Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.

Clinical Trial Outcome Measures

Primary Measures

  • Disease-free survival (DFS)
    • Time Frame: 3-year DFS

Secondary Measures

  • Clinical gynecologic endocrine function
    • Time Frame: 1-year period
    • To observe the level of female hormone,i.e., estrogen, FSH, LH
  • Quality of Life
    • Time Frame: 3-year period
  • Overall Survival (OS)
    • Time Frame: 3-year OS

Participating in This Clinical Trial

Inclusion Criteria

  • FIGO stage: ⅠA, endometrial carcinoma; – Female, Chinese women; – premenopausal women; – ≤ 50 years old; – Pathological diagnosis by curettage/hysteroscopy : G1 – No prior treatment; – Provide written informed consent. Exclusion Criteria:

  • The suspicious metastasis of ovarian; – Family history of ovarian cancer; – Suffering from other malignancies; – Concurrently participating in other clinical trials; – Unable or unwilling to sign informed consents; – Unable or unwilling to abide by protocol.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ding Ma
  • Collaborator
    • Shandong University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital – Huazhong University of Science and Technology
  • Overall Official(s)
    • Beihua Kong, MD, PhD, Study Chair, Shandong University

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