search
Back to results

Effect of Fertility-sparing Therapy of Early Endometrial Cancer (ECFerSp)

Primary Purpose

Endometrial Cancer, Fertility

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metformin
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial cancer, Atypical hyperplasia, Fertility-preserving, Remission time, Recurrence, Pregnancy, Progesterone receptor

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ages of no more than 40
  • with a strong desire of fertility preservation
  • International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1~2 with lesion confined in endometrium
  • pathology expression of progestin receptors (PRs) and estrogen receptors

Exclusion Criteria:

  • not eligible for pregnancy or delivery
  • evidence of suspected extrauterine or distant metastasis
  • complicated with any other malignancy
  • severe medical complications
  • contraindication of oral progestin
  • uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BMI≥25 group with metformin

BMI≥25 group without metformin

Arm Description

Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,

Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.

Outcomes

Primary Outcome Measures

Complete response rate
Histologically shows absence of pathological hyperplasia or carcinoma.

Secondary Outcome Measures

Pregnancy rate
Pregnancy test shows pregnancy after complete response.

Full Information

First Posted
March 14, 2018
Last Updated
May 24, 2018
Sponsor
Peking University People's Hospital
Collaborators
Peking University First Hospital, Peking University Third Hospital, Tianjin Medical University General Hospital, Maternal and Child Health Hospital of Hubei Province, First Affiliated Hospital, Sun Yat-Sen University, Qilu Hospital of Shandong University
search

1. Study Identification

Unique Protocol Identification Number
NCT03538704
Brief Title
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Acronym
ECFerSp
Official Title
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
Collaborators
Peking University First Hospital, Peking University Third Hospital, Tianjin Medical University General Hospital, Maternal and Child Health Hospital of Hubei Province, First Affiliated Hospital, Sun Yat-Sen University, Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
Detailed Description
This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Fertility
Keywords
Endometrial cancer, Atypical hyperplasia, Fertility-preserving, Remission time, Recurrence, Pregnancy, Progesterone receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMI≥25 group with metformin
Arm Type
Experimental
Arm Description
Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,
Arm Title
BMI≥25 group without metformin
Arm Type
No Intervention
Arm Description
Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin is given to patients 1-1.5g/d.
Primary Outcome Measure Information:
Title
Complete response rate
Description
Histologically shows absence of pathological hyperplasia or carcinoma.
Time Frame
through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
Pregnancy test shows pregnancy after complete response.
Time Frame
through study completion, an average of 3 months
Other Pre-specified Outcome Measures:
Title
Recurrence rate
Description
Pathology shows atypical hyperplasia or carcinoma again after complete response.
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages of no more than 40 with a strong desire of fertility preservation International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1~2 with lesion confined in endometrium pathology expression of progestin receptors (PRs) and estrogen receptors Exclusion Criteria: not eligible for pregnancy or delivery evidence of suspected extrauterine or distant metastasis complicated with any other malignancy severe medical complications contraindication of oral progestin uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianliu Wang, Professor
Phone
010-88324381
Email
wangjianliu1203@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Zhou, Professor
Phone
010-88324350
Email
zhourong@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianliu Wang, Professor
Organizational Affiliation
Department of Obstetrics and Gynecology, Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianliu Wang, Professor
Phone
010-88324381
Email
wangjianliu1203@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23021687
Citation
Gallos ID, Yap J, Rajkhowa M, Luesley DM, Coomarasamy A, Gupta JK. Regression, relapse, and live birth rates with fertility-sparing therapy for endometrial cancer and atypical complex endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2012 Oct;207(4):266.e1-12. doi: 10.1016/j.ajog.2012.08.011. Epub 2012 Aug 10.
Results Reference
result

Learn more about this trial

Effect of Fertility-sparing Therapy of Early Endometrial Cancer

We'll reach out to this number within 24 hrs