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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03538704
Other study ID # 2018ECFerSp
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2020

Study information

Verified date May 2018
Source Peking University People's Hospital
Contact Jianliu Wang, Professor
Phone 010-88324381
Email wangjianliu1203@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- ages of no more than 40

- with a strong desire of fertility preservation

- International Federation of Gynecology and Obstetrics (FIGO) 2009 stage ?a 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin
Metformin is given to patients 1-1.5g/d.

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (7)

Lead Sponsor Collaborator
Peking University People's Hospital First Affiliated Hospital, Sun Yat-Sen University, Maternal and Child Health Hospital of Hubei Province, Peking University First Hospital, Peking University Third Hospital, Qilu Hospital of Shandong University, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Obs — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Recurrence rate Pathology shows atypical hyperplasia or carcinoma again after complete response. through study completion, an average of 3 months
Primary Complete response rate Histologically shows absence of pathological hyperplasia or carcinoma. through study completion, an average of 3 months
Secondary Pregnancy rate Pregnancy test shows pregnancy after complete response. through study completion, an average of 3 months
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