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

Phase 3

Recruiting

• Conditions: Endometrial Cancer Stage I
• Interventions: Drug: Metformin

• Registration Number: NCT04792749
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-11
• Study Start: 2021-06-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Metformin treatment	Metformin	Patients who receive metformin in addition to progestin therapy

Primary Outcome Measures

Name	Time	Method
Treatment response rates	12 months after the initiation of the treatment	Measurements of the primary lesion by the RECIST criteria

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of