Effect of Fertility-sparing Therapy of Early Endometrial Cancer

Peking University People's Hospital80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometrial Cancer Fertility

Interventions

MetforminDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Complete response rate

Histologically shows absence of pathological hyperplasia or carcinoma.

Time frame: through study completion, an average of 3 months

Secondary Outcomes

Pregnancy rate

Pregnancy test shows pregnancy after complete response.

Time frame: through study completion, an average of 3 months

Central Contacts

Jianliu Wang, Professor

CONTACT

010-88324381 wangjianliu1203@163.com

Rong Zhou, Professor

CONTACT

010-88324350 zhourong@pku.edu.cn

Data from ClinicalTrials.gov

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