Brief Title
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
complete response rate
Secondary Outcome
disease-free survival
Condition
Endometrial Cancer
Intervention
Farlutal tab. 500mg/ Pfizer
Study Arms / Comparison Groups
Single group
Description: Farlutal tab. 500mg/ Pfizer to be administered
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
41
Start Date
July 15, 2018
Completion Date
November 30, 2022
Primary Completion Date
October 31, 2022
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
Gender
Female
Ages
20 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
Yong-Man Kim, MD Ph.D., 82-2-3010-3646, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03567655
Organization ID
KGOG 2020
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Korean Gynecologic Oncology Group
Study Sponsor
Yong-Man Kim, MD Ph.D., Study Chair, Korean Gynecologic Oncologic Group
Verification Date
June 2018