The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma (EC-02)

April 1, 2024 updated by: Ding Ma

The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital，Shandong University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total Hysterectomy (TH)
Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
Procedure: TH
Total hysterectomy
Procedure: BPLND
bilateral pelvic and para-aortic lymph node dissection
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.
Procedure: BPLND
bilateral pelvic and para-aortic lymph node dissection
Procedure: TH/BSO
Total hysterectomy and bilateral salpingo-oophorectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ding Ma

Collaborators

Shandong University
Huazhong University of Science and Technology
Zhejiang University

Investigators

  • Study Chair: Beihua Kong, MD, PhD, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimated)

March 29, 2013

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-GYN/EC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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