Endometrial Cancer Clinical Trial
Official title:
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
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.
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
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