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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04792749
Other study ID # MetforminEndometrialCancer
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2021
Est. completion date March 31, 2024

Study information

Verified date April 2023
Source Samsung Medical Center
Contact Joseph Noh, M.D.
Phone +82-10-9756-3249
Email joseph.noh@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 77
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin
Patients are given 750, 1500, and 2000 mgs of metformin per os daily (dose increases weekly, then maintain at 2000 mgs) in addition to 500 mgs of medroxyprogesterone acetate per os daily and levonorgestrel-releasing intrauterine device for the treatment of early stage endometrial cancer.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment response rates Measurements of the primary lesion by the RECIST criteria 3 months after the initiation of the treatment
Primary Treatment response rates Measurements of the primary lesion by the RECIST criteria 6 months after the initiation of the treatment
Primary Treatment response rates Measurements of the primary lesion by the RECIST criteria 9 months after the initiation of the treatment
Primary Treatment response rates Measurements of the primary lesion by the RECIST criteria 12 months after the initiation of the treatment
See also
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