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

Phase 2

• Conditions: Endometrial Cancer
• Interventions: Drug: Farlutal tab. 500mg/ Pfizer

• Registration Number: NCT03567655
• Lead Sponsor: Asan Medical Center

Brief 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

Study Timeline

• Study First Submitted: 2018-04-03
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-22
• Last Update Submitted: 2018-06-22
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Study Start: 2018-07-15
• Primary Completion: 2022-10-31
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group	Farlutal tab. 500mg/ Pfizer	Farlutal tab. 500mg/ Pfizer to be administered

Primary Outcome Measures

Name	Time	Method
complete response rate	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.

Secondary Outcome Measures

Name	Time	Method
fertility outcomes	every 3 months during 24 months from time of obtaining complete response	After obtaining complete response, this study aims to evaluate fertility outcomes. Fertility outcomes include menstruation history ( interval , duration , amount ), pregnancy try (date/ with or without assisted reproductive technology ), the number of pregnancy and the number of live birth.
Side effects of MPA, dosage of 50mg/day	From date of starting of MPA until the study end assessed up to 36 months	this study aims to evaluate the side effects of MPA, dosage of 50mg/day with treatment-related adverse events as assessed by CTCAE version4.0
disease-free survival	every 3 months during 24 months from time of obtaining complete response	After obtaining complete response, this study aims to evaluate disease-free survival. The disease-free survival (DFS) time is defined as the time from the date of cancer diagnosis to the date of recurrence or date of the last known follow-up investigation.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of