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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endometrial Neoplasms
- Sponsor
- Peking University People's Hospital
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- complete remission rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Wang Jianliu
Chief physician
Peking University People's Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
complete remission rate
Time Frame: 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 Outcomes
- recurrence time(2 years after complete remission)
- live birth rate(1 year after pregnancy)
- complete remission time(12 months after initial treatment)
- pregnancy rate(1 year after complete remission)
- complete remission rate(12 months after initial treatment)
- recurrence rate(2 years after complete remission)
- pregnancy time(1 year after complete remission)
- CA125(every 3-6 months until 5 years after initial treatment)
- pathological markers(every 3-6 months until 5 years after initial treatment)
- HOMA-IR(every 3-6 months until 5 years after initial treatment)
- adverse reactions(every 3-6 months until 5 years after initial treatment)