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Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

NCT05945407RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Peking University People's Hospital

Enrollment

Start Date

2016-08-01

Completion Date

2023-12-31

Study Type

INTERVENTIONAL

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.

Interventions

Indication-extended Fertility-sparing Therapy

Conditions

Endometrial NeoplasmsEndometrial Neoplasm MalignantEndometrial Neoplasm Malignant Stage ICarcinomaEndometrioidFertility Preservation

Eligibility

Age Range

18 Years – 45 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

complete remission rate

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

Time frame: 9 months after initial treatment

Secondary Outcomes

complete remission rate

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

Time frame: 6 months after initial treatment

complete remission rate

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

Time frame: 12 months after initial treatment

complete remission time

Time required to achieve complete remission.

Time frame: 12 months after initial treatment

recurrence rate

After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.

Time frame: 1 year after complete remission

recurrence rate

After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.

Time frame: 2 years after complete remission

recurrence time

Time of recurrence after complete remission.

Time frame: 2 years after complete remission

pregnancy rate

A pregnancy test shows pregnancy after complete remission.

Time frame: 1 year after complete remission

pregnancy time

Time of pregnancy.

Time frame: 1 year after complete remission

live birth rate

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

Time frame: 1 year after pregnancy

CA125

Used as a tumor marker for disease monitoring.

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

HOMA-IR

Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.

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

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).

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

adverse reactions

Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.

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

Locations

Peking University People's Hosoital, Beijing, China

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.