Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03567655|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Farlutal tab. 500mg/ Pfizer||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is a single arm, prospective multi-institutional study.|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||July 15, 2018|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Single group
Farlutal tab. 500mg/ Pfizer to be administered
Drug: Farlutal tab. 500mg/ Pfizer
- complete response rate [ Time Frame: 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.
- disease-free survival [ Time Frame: 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.
- fertility outcomes [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567655
|Contact: Jeong-yeol Park, MD Ph.D.||firstname.lastname@example.org|
|Contact: Dae-Yeon Kim, MD Ph.D.||email@example.com|
|Korea, Republic of|
|Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Study Chair:||Yong-Man Kim, MD Ph.D.||Korean Gynecologic Oncologic Group|