Endometrial Cancer Stage IPhase 3NCT04792749
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
A Phase 3 study testing Metformin in people with Endometrial Cancer Stage I, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer Stage I
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Joseph J Noh, MD, +82-10-9756-3249, joseph.noh@samsung.com
About this study
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.
- Conditions
- Endometrial Cancer Stage I
- Being tested
- Metformin
- Keywords
- Endometrial cancer, Metformin, Progestin, Fertility-sparing treatment
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Metformin treatment | Experimental | Patients who receive metformin in addition to progestin therapy Receives: Drug: Metformin |
| Conventional treatment | No intervention | Patients who receive progestin therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Measured: 3 months after the initiation of the treatment
Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Measured: 6 months after the initiation of the treatment
Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Measured: 9 months after the initiation of the treatment
Treatment response rates
Measurements of the primary lesion by the RECIST criteria
Measured: 12 months after the initiation of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Cancer Stage IStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Won Lee, Samsung Medical Center
- Investigators
- Jeong-Won Lee, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792749
- Sponsor's protocol ID
- MetforminEndometrialCancer
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04792749
- Acronym / sponsor ID
- MetforminEndometrialCancer
- Conditions
- Endometrial Cancer Stage I
- Keywords
- Endometrial cancer, Metformin, Progestin, Fertility-sparing treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin treatment | Experimental | Drug: MetforminPatients who receive metformin in addition to progestin therapy |
| Conventional treatment | No intervention | –Patients who receive progestin therapy only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminPatients 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. | Drug | Metformin treatment |
Primary outcome
Treatment response rates
Time frame: 3 months after the initiation of the treatment
Measurements of the primary lesion by the RECIST criteria
Treatment response rates
Time frame: 6 months after the initiation of the treatment
Measurements of the primary lesion by the RECIST criteria
Treatment response rates
Time frame: 9 months after the initiation of the treatment
Measurements of the primary lesion by the RECIST criteria
Treatment response rates
Time frame: 12 months after the initiation of the treatment
Measurements of the primary lesion by the RECIST criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Won Lee, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Endometrial Cancer Stage I, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Noh, M.D. (+82-10-9756-3249, joseph.noh@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response rates (time frame: 3 months after the initiation of the treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.