Brief Title
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Official Title
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
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.
Study Type
Interventional
Primary Outcome
Complete response rate
Secondary Outcome
Pregnancy rate
Condition
Endometrial Cancer
Intervention
Metformin
Study Arms / Comparison Groups
BMI≥25 group with metformin
Description: 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,
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
January 1, 2015
Completion Date
December 31, 2020
Primary Completion Date
March 31, 2020
Eligibility 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.
Gender
Female
Ages
18 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
Jianliu Wang, Professor, 010-88324381, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03538704
Organization ID
2018ECFerSp
Responsible Party
Sponsor
Study Sponsor
Peking University People's Hospital
Collaborators
Peking University First Hospital
Study Sponsor
Jianliu Wang, Professor, Study Chair, Department of Obstetrics and Gynecology, Peking University People's Hospital
Verification Date
May 2018