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临床试验/NCT03567655
NCT03567655Unknown2 期

Phase II Study of Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Stage I Endometrial Adenocarcinoma With Grade 2 Differentiation or Superficial Myomectomy Invasion

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
41
试验地点
1
主要终点
complete response rate

研究概览

简要总结

This registry aims to evaluate the efficacy of using high-dose oral progestin in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.

详细描述

The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young patients who desire to preserve their potential for fertility may find this standard treatment difficult to accept. Therefore, the conservative treatment for these patients has remained a challenge. A number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. However, there have been few prospective studies about hormonal therapy in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.

[Primary endpoint]: To evaluate the complete response rate [Sencondary endpoint]: To evaluate of disease-free survival rate, fertility outcomes and side effects of high-dose oral progestin.

To analyze predictive and prognostic biomarkers and clinicopathologic factors about response and recurrence after therapy, To analyze patient-reported outcomes.

[TREATMENT METHODS] Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion or patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium or patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion are administered medroxyprogesterone Acetate(MPA) at a dosage of 500 mg/day for 12 months.

Follow-up and treatment response assessment were implemented at a 3-month interval with MRI and dilatation and curettage (D&C) procedure. The biopsy findings are compared.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion based on Magnetic resonance image(MRI)
  • Patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium based on MRI
  • Patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion based on MRI
  • Patients who desire to preserve fertility potential
  • Patients signed the written informed consent voluntarily

排除标准

  • Patients who have severe underlying disease or complication
  • Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
  • Acute liver disease or kidney disease
  • Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker

研究组 & 干预措施

Single group

Experimental

Farlutal tab. 500mg/ Pfizer to be administered

干预措施: Farlutal tab. 500mg/ Pfizer (Drug)

结局指标

主要结局

complete response rate

时间窗: 12 months of taking oral MPA

Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion or patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium or patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion are administered medroxyprogesterone Acetate(MPA) at a dosage of 500 mg/day for 12 months.

次要结局

  • fertility outcomes(every 3 months during 24 months from time of obtaining complete response)
  • Side effects of MPA, dosage of 50mg/day(From date of starting of MPA until the study end assessed up to 36 months)
  • disease-free survival(every 3 months during 24 months from time of obtaining complete response)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong-Yeol Park

Clinical associate professor

Asan Medical Center

研究点 (1)

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