Clinical trial NCT03567655: Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: medroxyprogestrone acetate
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Gynecologic Oncology Group
First posted: 2018-06-26
Enrollment: 41
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a single arm, prospective multi-institutional study.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

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

Primary outcomes:
measure: complete response rate
timeFrame: 12 months of taking oral MPA
Secondary outcomes:
measure: disease-free survival
timeFrame: every 3 months during 24 months from time of obtaining complete response
measure: fertility outcomes
timeFrame: every 3 months during 24 months from time of obtaining complete response
measure: Side effects of MPA, dosage of 50mg/day
timeFrame: From date of starting of MPA until the study end assessed up to 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Korean Gynecologic Oncologic Group
name: Yong-Man Kim, MD Ph.D.
role: STUDY_CHAIR
References:
citation: Park JY, Nam JH. Progestins in the fertility-sparing treatment and retreatment of patients with primary and recurrent endometrial cancer. Oncologist. 2015 Mar;20(3):270-8. doi: 10.1634/theoncologist.2013-0445. Epub 2015 Feb 11.
citation: Bokhman JV, Chepick OF, Volkova AT, Vishnevsky AS. Can primary endometrial carcinoma stage I be cured without surgery and radiation therapy? Gynecol Oncol. 1985 Feb;20(2):139-55. doi: 10.1016/0090-8258(85)90135-0.
citation: Kempson RL, Pokorny GE. Adenocarcinoma of the endometrium in women aged forty and younger. Cancer. 1968 Apr;21(4):650-62. doi: 10.1002/1097-0142(196804)21:43.0.co;2-p. No abstract available.
citation: Skouby SO. The rationale for a wider range of progestogens. Climacteric. 2000 Dec;3 Suppl 2:14-20.