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

April 12, 2023 updated by: Jeong-Won Lee, Samsung Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin treatment
Patients who receive metformin in addition to progestin therapy
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.
No Intervention: Conventional treatment
Patients who receive progestin therapy only

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jeong-Won Lee, M.D., Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MetforminEndometrialCancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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