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

Primary Purpose

Endometrial Cancer Stage I

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer Stage I focused on measuring Endometrial cancer, Metformin, Progestin, Fertility-sparing treatment

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Metformin treatment

Conventional treatment

Arm Description

Patients who receive metformin in addition to progestin therapy

Patients who receive progestin therapy only

Outcomes

Primary Outcome Measures

Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Treatment response rates
Measurements of the primary lesion by the RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
March 8, 2021
Last Updated
April 12, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04792749
Brief Title
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Official Title
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer Stage I
Keywords
Endometrial cancer, Metformin, Progestin, Fertility-sparing treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin treatment
Arm Type
Experimental
Arm Description
Patients who receive metformin in addition to progestin therapy
Arm Title
Conventional treatment
Arm Type
No Intervention
Arm Description
Patients who receive progestin therapy only
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment response rates
Description
Measurements of the primary lesion by the RECIST criteria
Time Frame
3 months after the initiation of the treatment
Title
Treatment response rates
Description
Measurements of the primary lesion by the RECIST criteria
Time Frame
6 months after the initiation of the treatment
Title
Treatment response rates
Description
Measurements of the primary lesion by the RECIST criteria
Time Frame
9 months after the initiation of the treatment
Title
Treatment response rates
Description
Measurements of the primary lesion by the RECIST criteria
Time Frame
12 months after the initiation of the treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Noh, M.D.
Phone
+82-10-9756-3249
Email
joseph.noh@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Won Lee, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph J Noh, MD
Phone
+82-10-9756-3249
Email
joseph.noh@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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