Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer

Endometrial Cancer Stage I Clinical Trial

Official title:

Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792749
• Other study ID #: MetforminEndometrialCancer
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Endometrial Cancer Stage I
• Endometrial Neoplasms

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