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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin treatment | Experimental | Patients who receive metformin in addition to progestin therapy |
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| Conventional treatment | No Intervention | Patients who receive progestin therapy only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Noh, M.D. | Contact | +82-10-9756-3249 | joseph.noh@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong-Won Lee, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |