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

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ClinicalTrials.gov Identifier: NCT03538704
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
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
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Fertility Drug: Metformin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMI≥25 group with metformin
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,
Drug: Metformin
Metformin is given to patients 1-1.5g/d.

No Intervention: BMI≥25 group without metformin
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.



Primary Outcome Measures :
  1. Complete response rate [ Time Frame: through study completion, an average of 3 months ]
    Histologically shows absence of pathological hyperplasia or carcinoma.


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: through study completion, an average of 3 months ]
    Pregnancy test shows pregnancy after complete response.


Other Outcome Measures:
  1. Recurrence rate [ Time Frame: through study completion, an average of 3 months ]
    Pathology shows atypical hyperplasia or carcinoma again after complete response.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538704


Contacts
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Contact: Jianliu Wang, Professor 010-88324381 wangjianliu1203@163.com
Contact: Rong Zhou, Professor 010-88324350 zhourong@pku.edu.cn

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Jianliu Wang, Professor    010-88324381    wangjianliu1203@163.com   
Sponsors and Collaborators
Peking University People's Hospital
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
Investigators
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Study Chair: Jianliu Wang, Professor Department of Obstetrics and Gynecology, Peking University People's Hospital

Publications of Results:
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03538704     History of Changes
Other Study ID Numbers: 2018ECFerSp
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking University People's Hospital:
Endometrial cancer
Atypical hyperplasia
Fertility-preserving
Remission time
Recurrence
Pregnancy
Progesterone receptor

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs