Effect of Fertility-sparing Therapy of Early Endometrial Cancer

Endometrial Cancer Clinical Trial

— ECFerSp  

Official title:

Effect of Fertility-sparing Therapy of Early Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538704
• Other study ID #: 2018ECFerSp
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Fertility

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