GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

August 6, 2025 updated by: Xiaojun Chen

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment

To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There were more and more women with early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH) who want to preserve fertility.

Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). With long duration of treatment, there will be more side effects such as weight gain, impaired liver function, endometrial injury, ovarian reserve inhibition etc. which will decrease the efficacy of conservative treatment. Previous researches had shown that GnRHa plus letrozole could be a better second-line treatment for obese progestin-insensitive patients. Till now, no similar studies were found, so we design this study to explore the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC and EAH patients to provide new evidences for improving conservative treatment efficacy. We defined obese patients as these with BMI ≥ 30kg/m2.

This will be a single-centred prospective pilot study. Patients diagnosed as obese progestin-insensitive EEC by dilatation and curettage (D&C) or hysteroscopy will be enrolled. The primary endpoint is cumulative complete response (CR) rate at 28 weeks of treatment. The secondary endpoints include adverse events, duration of complete response, recurrent rate, pregnancy rate and quality of life of patients.

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 2
  • Phase 3

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

  • Name: Xiaojun Chen, PhD
  • Phone Number: 8602133189900
  • Email: cxjlhjj@163.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Obstetrics and Gynecology Hospital, Fudan University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Tenth People's Hospital of Tongji University
        • 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:

  • Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
  • BMI≥30kg/m2
  • No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound

  • Using progestin, any of the following therapy, as first-line treatment:

    1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
    2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
    3. LNG-IUS inserted

  • Progestin-insensitive:

    1. remained with stable disease after 7 months of progestin use
    2. did not achieve CR after 10 months of progestin use
  • Have a desire for remaining reproductive function or uterus
  • Good compliance with adjunctive treatment and follow-up

Exclusion Criteria:

  • Combined with severe medical disease or severely impaired liver and kidney function
  • Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
  • Patients with other types of endometrial cancer or other malignant tumors of the reproductive system
  • Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole
  • Strong request for uterine removal or other conservative treatment
  • Known or suspected pregnancy
  • Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
  • Smoker(>15 cigarettes a day)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese EEC group

This group including 29 EEC cases. Interventional Study Model was Simon two-stage optimal design. Eleven patients were needed for the first stage, and if eight or more patients achieved CR at 28 weeks, the trial can enter into the second stage.

Then every 12 to 16 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Drug: GnRH antagonist
Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks, and the maximum treatment courses will be 6. If the patient get CR within 6 courses, another 2 courses will be used as consolidation therapy.
Drug: Letrozole 2.5mg
2.5mg po qd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rates within 28 weeks of treatment
Time Frame: Up to 28 weeks
The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 to 16 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment.
Up to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Through study completion, an average of 28 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.
Through study completion, an average of 28 weeks
Time to achieve complete response
Time Frame: Up to 28 weeks
The median CR time will be calculated.
Up to 28 weeks
Relapse rates
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Rates of fertility outcomes
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Compliance
Time Frame: Through study completion, an average of 28 weeks
Data on treatment and hysteroscopy management will be collected, and deviations from study protocol will be recorded in writing. For example, the time of drug interruptions due to related toxicities or AEs, and delay of hysteroscopy for personal reasons.
Through study completion, an average of 28 weeks

Collaborators and Investigators

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

Sponsor

Xiaojun Chen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 13, 2022

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53211030-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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