Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

Peking University

Status: Enrolling

Conditions: Endometrial Neoplasm Malignant; Endometrial Neoplasm Malignant Stage I; Carcinoma, Endometrioid; Fertility Preservation; Endometrial Neoplasms

Treatments: Combination Product: Indication-extended Fertility-sparing Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05945407

2017ECFerSp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

57 participants in 2 patient groups

Myometrial invasion group

Experimental group

Description:

Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium.

Treatment:

Combination Product: Indication-extended Fertility-sparing Therapy

No myometrial invasion group

Other group

Description:

Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.

Treatment:

Combination Product: Indication-extended Fertility-sparing Therapy