The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer

January 14, 2019 updated by: Min Wang

The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer

Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.

Study Overview

Detailed Description

Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.

Study Type

Interventional

Enrollment (Anticipated)

170

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 Contact

  • Name: Min Wang, PHD.
  • Phone Number: 18940251222
  • Email: wm21st@126.com

Study Contact Backup

Study Locations

    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospitaol of China Medical University
        • Contact:

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Premenopausal women, age ≤ 50 years
  2. Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
  3. Clinical consideration of IA (<1/2 muscle infiltration);
  4. First-time treatment
  5. The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.

Exclusion Criteria:

  1. At the same time participate in other clinical trials;
  2. Can not tolerate surgery;
  3. Ovarian suspicious metastasis;
  4. Have a family history of ovarian cancer;
  5. Incorporate other malignant tumors;
  6. Preoperative CA125 abnormal persons

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radical surgery group
Endometrial cancer radical surgery to be administered in this arm.
Take hysterectomy and bilateral adnexectomy.
Experimental: fertility preservation group
Fertility-sparing surgery to be administered in this arm.
Take endometrectomy , preserve uterus and bilateral ovaries.
Experimental: ovarian preservation group
Ovarian preservation surgery to be administered in this arm.
Take hysterectomy,preserve bilateral ovaries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total survival Time
Time Frame: 6 months
calculate the time from patients enter the group to death
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of Ovarian volume
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure the ovarian volume dynamically by ultrasonography
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
the change of endocrine function evaluation
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure the endocrine function(hormone level) dynamically by blood detection
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Progression Free Survival
Time Frame: 6 months
calculate the time from patients enter the group to tumor progression
6 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Min Wang, PHD., Shengjing Hospital

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 (Anticipated)

January 10, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Endometrial Cancer

Clinical Trials on endometrial cancer radical surgery

3
Subscribe