Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

Endometrial Neoplasms Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945407
• Other study ID #: 2017ECFerSp
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Endometrioid
• Endometrial Neoplasm Malignant
• Endometrial Neoplasm Malignant Stage I
• Endometrial Neoplasms
• Fertility Preservation
• Neoplasms

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