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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04792749
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer Stage I	Drug: Metformin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 77 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Treatment response rates [3 months after the initiation of the treatment]

   Measurements of the primary lesion by the RECIST criteria

2. Treatment response rates [6 months after the initiation of the treatment]

   Measurements of the primary lesion by the RECIST criteria

3. Treatment response rates [9 months after the initiation of the treatment]

   Measurements of the primary lesion by the RECIST criteria

4. Treatment response rates [12 months after the initiation of the treatment]

   Measurements of the primary lesion by the RECIST criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeong-Won Lee, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04792749
• Other Study ID Numbers: MetforminEndometrialCancer
• First Posted: Mar 11, 2021
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Jeong-Won Lee, Professor, Samsung Medical Center: Endometrial cancer; Metformin; Progestin; Fertility-sparing treatment
• Additional relevant MeSH terms: Endometrial Neoplasms; Metformin

Study Results

No Results Posted as of Sep 28, 2021