Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Megestrol Acetate 40 MG.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer Stage I, Endometrial Hyperplasia. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions：When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn). Participants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology
Interventions
- Drug Megestrol Acetate 40 MG
160mg/one time/day
Primary outcome measures
- 24-week complete response(CR) rate [Time frame: baseline,12 weeks after treatment,and 24 weeks of treatment]
Secondary outcome measures (5)
- 36-week CR rate [Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment]
- 48-week CR rate [Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment]
- treatment-related adverse events [Time frame: baseline,12 weeks after treatment,and 24 weeks of treatment]
- recurrent rate [Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment]
- pregnancy rate [Time frame: 1-year after CR]
Eligibility criteria
Inclusion criteria
- 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs
Exclusion criteria
- 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Women's Hospital School of Medicine Zhejiang University — Hangzhou
Identifiers
NCT: NCT06417736 · PRO2023-3614