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

Study Overview
=================
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.

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

Conditions
-----------------
Endometrial Cancer Stage I

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin treatment<br>Patients who receive metformin in addition to progestin therapy | Drug: Metformin<br>* 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.<br>|
| No Intervention: Conventional treatment<br>Patients who receive progestin therapy only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response rates | Measurements of the primary lesion by the RECIST criteria | 3 months after the initiation of the treatment | 
| Treatment response rates | Measurements of the primary lesion by the RECIST criteria | 6 months after the initiation of the treatment | 
| Treatment response rates | Measurements of the primary lesion by the RECIST criteria | 9 months after the initiation of the treatment | 
| Treatment response rates | Measurements of the primary lesion by the RECIST criteria | 12 months after the initiation of the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial cancer, Metformin, Progestin, Fertility-sparing treatment