Brief Title
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Official Title
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Brief Summary
The purpose of the study is to investigate the effects of metformin in addition to the
conventional progestin therapy in the fertility-sparing treatment of early stage endometrial
cancer.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Treatment response rates
Condition
Endometrial Cancer Stage I
Intervention
Metformin
Study Arms / Comparison Groups
Metformin treatment
Description: Patients who receive metformin in addition to progestin therapy
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
77
Start Date
April 1, 2021
Completion Date
March 31, 2023
Primary Completion Date
December 31, 2022
Eligibility Criteria
Inclusion Criteria:
- Endometrial cancer radiologic International Federation of Obstetrics and Gynecology
(FIGO) stage IA patients
- Endometrioid endometrial cancer patients
- FIGO cellular differentiation grade 1 patients
- Patients who wish to preserve fertility
- Patients who understand that the recommended treatment of endometrial cancer is
surgical treatment even in early stages, but still wish to preserve fertility and
avoid surgical treatment
- Patients who have good performance status (Eastern Cooperation Oncology Group (ECOG)
performance score equal to or greater than 3)
- Patients who are not contraindicated to the progestin therapy
- Patients who are not contraindicated to the use of metformin
Exclusion Criteria:
- Patients who have already received chemotherapeutic or radiotherapeutic treatments for
endometrial cancer
- Patients whose disease is already advanced and not indicated for fertility-sparing
treatment
- Patients whose tumor cellular differentiation grade is greater than FIGO grade 1
Gender
Female
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jeong-Won Lee, M.D., Ph.D., +82-10-9756-3249, [email protected]
Administrative Informations
NCT ID
NCT04792749
Organization ID
MetforminEndometrialCancer
Responsible Party
Principal Investigator
Study Sponsor
Samsung Medical Center
Study Sponsor
Jeong-Won Lee, M.D., Ph.D., Principal Investigator, Samsung Medical Center
Verification Date
March 2021