Overview
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.
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.
