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Trial record 3 of 6 for:    "Endometrial Adenocarcinoma" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

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
Sponsor:
Collaborator:
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Jeong-Yeol Park, 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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Farlutal tab. 500mg/ Pfizer Phase 2

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


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single group
Farlutal tab. 500mg/ Pfizer to be administered
Drug: Farlutal tab. 500mg/ Pfizer
Medroxyprogesterone Acetate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jeong-yeol Park, MD Ph.D. 82-2-3010-3646 objyjypark@amc.seoul.kr
Contact: Dae-Yeon Kim, MD Ph.D. 82-2-3010-3748 kdyog@amc.seoul.kr

Locations
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Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Korean Gynecologic Oncology Group
Investigators
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Study Chair: Yong-Man Kim, MD Ph.D. Korean Gynecologic Oncologic Group

Publications:
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Responsible Party: Jeong-Yeol Park, Clinical associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03567655     History of Changes
Other Study ID Numbers: KGOG 2020
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jeong-Yeol Park, Asan Medical Center:
medroxyprogestrone acetate
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Medroxyprogesterone Acetate
Medroxyprogesterone
Progestins
Hormones
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral