Status:
UNKNOWN
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Endometrial Cancer Stage I
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04792749
Start Date
June 1 2021
End Date
March 31 2024
Last Update
April 13 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351