Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
- Registration Number
- NCT04792749
- Lead Sponsor
- Samsung Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 77
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Metformin treatment Metformin Patients who receive metformin in addition to progestin therapy
- Primary Outcome Measures
Name Time Method Treatment response rates 12 months after the initiation of the treatment Measurements of the primary lesion by the RECIST criteria
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie metformin's role in enhancing progestin therapy for endometrial cancer?
How does metformin combination therapy compare to standard progestin-only treatment in early endometrial cancer remission rates?
Which biomarkers (e.g., metabolic or genetic) predict response to metformin in fertility-sparing endometrial cancer protocols?
What are the potential adverse events of metformin in endometrial cancer patients undergoing progestin therapy?
Are there alternative insulin-sensitizing agents or combination strategies for fertility-sparing endometrial cancer treatment?
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of