Endometrial Cancer Stage I
Conditions
Keywords
Endometrial cancer, Metformin, Progestin, Fertility-sparing treatment
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.
Interventions
DRUGMetformin
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.
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response rates | 3 months after the initiation of the treatment | Measurements of the primary lesion by the RECIST criteria |
Countries
South Korea
Contacts
Primary ContactJoseph Noh, M.D.
Outcome results
None listed