NCT04792749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

March 8, 2021

Last Update Submit

April 12, 2023

Conditions

Endometrial Cancer Stage I

Keywords

Endometrial cancerMetforminProgestinFertility-sparing treatment

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Metformin treatment

EXPERIMENTAL

Patients who receive metformin in addition to progestin therapy

Drug: Metformin

Conventional treatment

NO INTERVENTION

Patients who receive progestin therapy only

Interventions

MetforminDRUG

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.

Metformin treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jeong-Won Lee, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Noh, M.D.

CONTACT

+82-10-9756-3249joseph.noh@samsung.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)