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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
complete remission rate
时间窗: 9 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
次要结局
- 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)
研究者
Wang Jianliu
Chief physician
Peking University People's Hospital