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NCT Number: NCT06417736

Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

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

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Key information

Conditions

Endometrial Cancer Stage I Endometrial Hyperplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 321006, China

Location status: Recruiting

Location contact

Li Yang

CONTACT

[email protected]

0086-18268165386

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Megestrol Acetate 40 MG

Drug

160mg/one time/day

Other names: membrane-inhibiting formula

Primary outcomes

  1. 24-week complete response(CR) rate

    Time frame: baseline,12 weeks after treatment,and 24 weeks of treatment

    The treatment response:complete response,no endometrial lesion

Secondary outcomes

  1. 36-week CR rate

    Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment

    The treatment response:complete response,no endometrial lesion

  2. 48-week CR rate

    Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

    The treatment response:complete response,no endometrial lesion

  3. treatment-related adverse events

    Time frame: baseline,12 weeks after treatment,and 24 weeks of treatment

    analyze the safety of the drug

  4. recurrent rate

    Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

    cumulative recurrent rate

  5. pregnancy rate

    Time frame: 1-year after CR

    long term fertility results

Other outcomes

  1. CR in different molecular classification

    Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

    Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn)

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Li, Doctor

CONTACT

[email protected]

0086-18268165386

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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