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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05945407
Other study ID # 2017ECFerSp
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date December 31, 2027

Study information

Verified date July 2023
Source Peking University People's Hospital
Contact Jianliu Wang, Professor
Phone 0086-010-88324381
Email wangjianliu1203@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 57
Est. completion date December 31, 2027
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Peking University People's Hosoital Beijing Beijing

Sponsors (10)

Lead Sponsor Collaborator
Peking University People's Hospital Beijing Chao Yang Hospital, Guang'anmen Hospital, Chinese 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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary complete remission rate 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 complete remission rate No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. 6 months after initial treatment
Secondary complete remission rate No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. 12 months after initial treatment
Secondary complete remission time Time required to achieve complete remission. 12 months after initial treatment
Secondary recurrence rate After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs. 1 year after complete remission
Secondary recurrence rate After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs. 2 years after complete remission
Secondary recurrence time Time of recurrence after complete remission. 2 years after complete remission
Secondary pregnancy rate A pregnancy test shows pregnancy after complete remission. 1 year after complete remission
Secondary pregnancy time Time of pregnancy. 1 year after complete remission
Secondary live birth rate The live birth rate is defined as the ratio of live births to pregnancies. 1 year after pregnancy
Secondary CA125 Used as a tumor marker for disease monitoring. every 3-6 months until 5 years after initial treatment
Secondary HOMA-IR 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
Secondary pathological markers 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
Secondary adverse reactions 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
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