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

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Samsung Medical Center

Status and phase

Enrolling
Phase 3

Conditions

Endometrial Cancer Stage I

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT04792749
MetforminEndometrialCancer

Details and patient eligibility

About

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.

Enrollment

77 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Metformin treatment
Experimental group
Description:
Patients who receive metformin in addition to progestin therapy
Treatment:
Drug: Metformin
Conventional treatment
No Intervention group
Description:
Patients who receive progestin therapy only

Trial contacts and locations

1

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Central trial contact

Joseph Noh, M.D.

Data sourced from clinicaltrials.gov

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