Effect of Fertility-sparing Therapy of Early Endometrial Cancer

Not Applicable

• Conditions: Endometrial Cancer; Fertility
• Interventions: Drug: Metformin

• Registration Number: NCT03538704
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2018-03-14
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-24
• Last Update Submitted: 2018-05-24
• Study First Posted: 2018-05-29
• Last Update Posted: 2018-05-29
• Primary Completion: 2020-03-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI≥25 group with metformin	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,

Primary Outcome Measures

Name	Time	Method
Complete response rate	through study completion, an average of 3 months	Histologically shows absence of pathological hyperplasia or carcinoma.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	through study completion, an average of 3 months	Pregnancy test shows pregnancy after complete response.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China