Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

July 12, 2023 updated by: Wang Jianliu, Peking University People's Hospital

Establishment of a Network Platform for Fertility-sparing in Patients With Endometrial Cancer and Study on Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer.

The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hosoital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage IA (FIGO 2009) ;
  • Pathological diagnosis: endometrial adenocarcinoma G1-G2;
  • MRI or ultrasound: tumor limited to endometrium or invading less than 1/2 of myometrium；
  • 18 years old ≤ Age ≤ 45 years old;
  • With a strong desire for fertility preservation；
  • Sign the informed consent.

Exclusion Criteria:

  • Complicated with any other malignancy；
  • Contraindications to conservative treatment；
  • Contraindications to progestin use;
  • Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myometrial invasion group
Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium.
Combination product: Indication-extended Fertility-sparing Therapy
Patients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be used for consolidation treatment for another 1-3 months. Subsequently, if the patient has no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone", "Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be encouraged to conceive either by an expectation for 3-6 months, or by assisted reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no longer require sparing fertility; 5) serious adverse reactions.
Other: No myometrial invasion group
Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.
Combination product: Indication-extended Fertility-sparing Therapy
Patients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be used for consolidation treatment for another 1-3 months. Subsequently, if the patient has no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone", "Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be encouraged to conceive either by an expectation for 3-6 months, or by assisted reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no longer require sparing fertility; 5) serious adverse reactions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete remission rate
Time Frame: 9 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
9 months after initial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete remission rate
Time Frame: 6 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
6 months after initial treatment
complete remission rate
Time Frame: 12 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
12 months after initial treatment
complete remission time
Time Frame: 12 months after initial treatment
Time required to achieve complete remission.
12 months after initial treatment
recurrence rate
Time Frame: 1 year after complete remission
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
1 year after complete remission
recurrence rate
Time Frame: 2 years after complete remission
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
2 years after complete remission
recurrence time
Time Frame: 2 years after complete remission
Time of recurrence after complete remission.
2 years after complete remission
pregnancy rate
Time Frame: 1 year after complete remission
A pregnancy test shows pregnancy after complete remission.
1 year after complete remission
pregnancy time
Time Frame: 1 year after complete remission
Time of pregnancy.
1 year after complete remission
live birth rate
Time Frame: 1 year after pregnancy
The live birth rate is defined as the ratio of live births to pregnancies.
1 year after pregnancy
CA125
Time Frame: every 3-6 months until 5 years after initial treatment
Used as a tumor marker for disease monitoring.
every 3-6 months until 5 years after initial treatment
HOMA-IR
Time Frame: every 3-6 months until 5 years after initial treatment
Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.
every 3-6 months until 5 years after initial treatment
pathological markers
Time Frame: every 3-6 months until 5 years after initial treatment
Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).
every 3-6 months until 5 years after initial treatment
adverse reactions
Time Frame: every 3-6 months until 5 years after initial treatment
Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.
every 3-6 months until 5 years after initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Peking Union Medical College Hospital
Peking University Third Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Shengjing Hospital
Third Military Medical University
Beijing Chao Yang Hospital
Tianjin Medical University General Hospital
Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences

Investigators

  • Study Director: Jianliu Wang, Professor, Peking university People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017ECFerSp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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