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

NCT06417736 | Recruiting

• 1 other identifier: PRO2023-3614
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Cancer Stage I; Endometrial Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 24-week complete response(CR) rate

  The treatment response:complete response,no endometrial lesion

  baseline,12 weeks after treatment,and 24 weeks of treatment

Secondary Outcomes (5)

• 36-week CR rate

  baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment

• 48-week CR rate

  baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

• treatment-related adverse events

  baseline,12 weeks after treatment,and 24 weeks of treatment

• recurrent rate

  baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

• pregnancy rate

  1-year after CR

Other Outcomes (1)

• CR in different molecular classification

  baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

Study Arms (1)

membrane-inhibiting formula combined with oral progestins

EXPERIMENTAL

Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks

Drug: Megestrol Acetate 40 MG

Interventions

Megestrol Acetate 40 MG DRUG

160mg/one time/day

Also known as: membrane-inhibiting formula

membrane-inhibiting formula combined with oral progestins

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 321006, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yang Li, Doctor

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Li, Doctor

CONTACT

0086-18268165386; 5516015@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: December 1, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 16, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)