NCT03567655

Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. \[INVESTIGATIONAL PRODUCT\] General Name/Brand name:Farlutal tab. 500mg/ Pfizer

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Farlutal tab. 500mg/ Pfizer	Medroxyprogesterone Acetate

Timeline

• Start date: 2018-07-15
• Primary completion: 2022-10-31
• Completion: 2022-11-30
• First posted: 2018-06-26
• Last updated: 2018-06-26

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study