Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer

July 13, 2024 updated by: Wang Jianliu, Peking University People's Hospital
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to explore effective treatment options and pregnancy outcomes for G2 EC patients who wish to preserve their fertility. It compares the efficacy of monotherapy with progesterone versus combined therapy to determine the best treatment option.

This study is a multi-center, prospective, randomized controlled trial that collects hospital and outpatient records of uterine endometrioid adenocarcinoma patients who undergo fertility-sparing treatment at 10 units from October 2022. The basic items specified in the study are registered.

Selection criteria: Pathological diagnosis of endometrioid adenocarcinoma G2, MRI or ultrasound confirmed localization of the lesion within the endometrium, FIGO (FIGO, 2009) staging IA, age ≤ 45 years, and those who wish to preserve reproductive function, signed informed consent. Exclusion criteria: Tumor invasion of the muscle layer, FIGO (FIGO, 2009) staging IB or higher, tumor differentiation as G1, G3, or non-endometrioid adenocarcinoma, coexistence of malignant tumors in other sites, contraindications or drug prohibitions for conservative treatment, or judged by the investigator to be unsuitable for childbearing. Exclusion criteria: Violation of the treatment protocol; failure to take medication as prescribed, affecting the judgment of drug efficacy; incomplete data affecting the judgment of efficacy and safety. Withdrawal criteria: Intolerance of the used drugs or the appearance of serious complications, including venous or arterial thromboembolism, liver failure, renal failure, anaphylaxis, uterine perforation, etc.; no response to treatment or disease progression during drug therapy; when the patient requests termination of treatment.

Treatment Plan: The treatment plan was randomly divided into two groups. Group 1 was a single-drug treatment plan, with oral medroxyprogesterone acetate (MPA) 500mg/d or megestrol acetate (MA) 320mg/d; Group 2 was a combined treatment plan, with oral MPA 500mg/d/MA 320mg/d combined with the placement of levonorgestrel intrauterine system (LNG-IUS) in the uterus.

Since the treatment began, each 3-6 months is a course. At the end of each course, an endometrial biopsy is performed under hysteroscopy to conduct tissue pathological examination and evaluate the treatment effect. A vaginal color Doppler ultrasound is performed every month, and a pelvic MRI is re-evaluated as needed. Additionally, a side effect assessment is performed for each course, including weight, vaginal bleeding, breast discomfort, gastrointestinal symptoms, liver and kidney function, and thrombosis.

The efficacy assessment is divided into the following categories: (1) Complete Response (CR), (2) Partial Response (PR), (3) Disease Unresponsive or Stable Disease (NC/SD), (4) Disease Progression (PD), and (5) Relapse.

The main measurement indicator is the time required for the first complete remission. The secondary measurement indicators are the one-year complete remission rate, the two-year disease recurrence rate, the cumulative pregnancy rate, pregnancy duration, pregnancy outcomes, changes in serum indicators, and pathological markers.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Endometrioid adenocarcinoma G2, diagnosis by pathological.
  • The lesion is limited to the endometrium.
  • FIGO (2009) staging is IA.
  • Age less than 45.
  • Strongly request to preserve fertility.
  • Sign informed consent.

Exclusion Criteria:

  • The tumor has invaded the muscle layer.
  • FIGO (2009) stage IB or higher.
  • Endometrioid adenocarcinoma G1, G3, or non-endometrioid cancer
  • There are malignant tumors in other systems.
  • Have contraindications for conservative treatment or drug use.
  • Have been judged by the researcher to be unsuitable for childbearing.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients
Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
Compare the efficacy of mono-therapy with progesterone versus combined therapy to determine the best treatment option.
Other Names:
  • Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).
Experimental: The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients
Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).
Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
Compare the efficacy of mono-therapy with progesterone versus combined therapy to determine the best treatment option.
Other Names:
  • Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Time Required for Complete Remission for the First Time
Time Frame: 5 years
The time from the diagnosis of G2 endometrioid carcinoma to the first complete remission after fertility-preserving treatment.（year）
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year complete remission rate
Time Frame: 5 years
The percentage of patients who achieved complete remission after one year of fertility preservation treatment.
5 years
two-year disease recurrence rate
Time Frame: 5 years
The probability of recurrence within 2 years for patients who underwent treatment for preserving fertility and achieved complete remission.
5 years
cumulative pregnancy rate
Time Frame: 5 years
The percentage of pregnancies that occurred during the observation period.
5 years
pregnancy outcome
Time Frame: 5 years
The pregnancy outcomes in women who successfully conceived after undergoing fertility-sparing treatment. They can be categorized as: full-term delivery; premature delivery; miscarriage; stillbirth.
5 years

Collaborators and Investigators

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

Sponsor

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023G2ECFerSp

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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