Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer

June 22, 2018 updated by: Jeong-Yeol Park, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months of taking oral MPA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 3 months during 24 months from time of obtaining complete response
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.
every 3 months during 24 months from time of obtaining complete response
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
From date of starting of MPA until the study end assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korean Gynecologic Oncology Group

Investigators

  • Study Chair: Yong-Man Kim, MD Ph.D., Korean Gynecologic Oncologic Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2018

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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