Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer
NCT ID: NCT03567655
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
41 participants
INTERVENTIONAL
2018-07-15
2022-11-30
Brief Summary
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Detailed Description
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\[Primary endpoint\]: 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single group
Farlutal tab. 500mg/ Pfizer to be administered
Farlutal tab. 500mg/ Pfizer
Medroxyprogesterone Acetate
Interventions
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Farlutal tab. 500mg/ Pfizer
Medroxyprogesterone Acetate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
40 Years
FEMALE
No
Sponsors
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Korean Gynecologic Oncology Group
OTHER
Asan Medical Center
OTHER
Responsible Party
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Jeong-Yeol Park
Clinical associate professor
Principal Investigators
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Yong-Man Kim, MD Ph.D.
Role: STUDY_CHAIR
Korean Gynecologic Oncologic Group
Locations
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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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References
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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.
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.
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.
Skouby SO. The rationale for a wider range of progestogens. Climacteric. 2000 Dec;3 Suppl 2:14-20.
Other Identifiers
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KGOG 2020
Identifier Type: -
Identifier Source: org_study_id
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