Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
- Conditions
- Endometrial Neoplasm MalignantCarcinoma, EndometrioidEndometrial NeoplasmsEndometrial Neoplasm Malignant Stage IFertility Preservation
- Interventions
- Combination Product: Indication-extended Fertility-sparing Therapy
- Registration Number
- NCT05945407
- Lead Sponsor
- Peking University People's Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 57
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Myometrial invasion group Indication-extended Fertility-sparing Therapy Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium. No myometrial invasion group Indication-extended Fertility-sparing Therapy Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.
- Primary Outcome Measures
Name Time Method complete remission rate 9 months after initial treatment No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
- Secondary Outcome Measures
Name Time Method recurrence time 2 years after complete remission Time of recurrence after complete remission.
live birth rate 1 year after pregnancy The live birth rate is defined as the ratio of live births to pregnancies.
complete remission time 12 months after initial treatment Time required to achieve complete remission.
pregnancy rate 1 year after complete remission A pregnancy test shows pregnancy after complete remission.
complete remission rate 12 months after initial treatment No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
recurrence rate 2 years after complete remission After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
pregnancy time 1 year after complete remission Time of pregnancy.
CA125 every 3-6 months until 5 years after initial treatment Used as a tumor marker for disease monitoring.
pathological markers every 3-6 months until 5 years after initial treatment Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).
HOMA-IR every 3-6 months until 5 years after initial treatment Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.
adverse reactions every 3-6 months until 5 years after initial treatment Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.
Trial Locations
- Locations (1)
Peking University People's Hosoital
🇨🇳Beijing, Beijing, China