Actively Recruiting
Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2024-05-16
75
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and possible side effects of a membrane-inhibiting formula combined with oral progestins as a fertility-preserving treatment for women with early-stage endometrial cancer and endometrial hyperplasia. The study aims to find out whether this combination shortens the time needed for complete endometrial remission and to monitor outcomes such as treatment efficacy, side effects, recurrence, pregnancy rates, and time to pregnancy in different molecular subtypes of the disease. Participants will take the membrane-inhibiting formula along with the oral progestin drug megestrol acetate at a dose of 160mg once daily for 24 weeks. They will visit the clinic every 3 months for checkups, tests, and hysteroscopy to monitor progress. The study tracks responses at multiple time points including baseline, 12, 24, 36, and 48 weeks to assess complete remission rates and treatment-related adverse events. During the study, participants will keep a diary of examination results and pathology findings. Researchers will monitor safety and treatment effects through regular clinical visits and tests. The primary outcome is the complete response rate at 24 weeks, with additional evaluations up to 48 weeks and pregnancy outcomes assessed one year after remission. The total participation duration includes ongoing follow-up visits to assess recurrence and pregnancy rates.
CONDITIONS
Brief Title
Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 45 years with a strong desire to preserve fertility
- Pathologically diagnosed with primary grade 1 or grade 2 endometrioid endometrial carcinoma or endometrial hyperplasia
- No signs of suspicious myometrial invasion by enhanced MRI
- No signs of suspicious extrauterine metastasis by enhanced CT and lung CT scan
You will not qualify if you...
- Contraindications for pregnancy
- No fertility requirement
- Presence of myometrial invasion or extrauterine metastasis
- Pathologically diagnosed with primary grade 3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma
- Any disease or symptom that may affect study participation or result interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive a membrane-inhibiting formula combined with oral progestins (Megestrol acetate 160mg/day) for 24 weeks.
Visits at baseline, 12 weeks, and 24 weeks of treatment
Duration - Up to 1 year after treatment
Participants are monitored for treatment response and pregnancy for up to 1 year after complete response.
Visits at 36 weeks, 48 weeks of treatment, and 1 year after complete response
Trial Site Locations
Total: 1 location
1
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 321006
Actively Recruiting
Research Team
Y
Yang Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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