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NCT Number: NCT05945407

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Indication-extended Fertility-sparing Therapy

Combination Product

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. complete remission time

    Time frame: 12 months after initial treatment

    Time required to achieve complete remission.

  4. 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.

  5. 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.

  6. recurrence time

    Time frame: 2 years after complete remission

    Time of recurrence after complete remission.

  7. pregnancy rate

    Time frame: 1 year after complete remission

    A pregnancy test shows pregnancy after complete remission.

  8. pregnancy time

    Time frame: 1 year after complete remission

    Time of pregnancy.

  9. live birth rate

    Time frame: 1 year after pregnancy

    The live birth rate is defined as the ratio of live births to pregnancies.

  10. CA125

    Time frame: every 3-6 months until 5 years after initial treatment

    Used as a tumor marker for disease monitoring.

  11. 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.

  12. 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).

  13. 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.

Study contacts

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

Jianliu Wang, Professor

CONTACT

[email protected]

0086-010-88324381

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

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

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2023
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
Jul 14, 2023

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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