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

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Metformin

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