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

NCT03567655 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: KGOG 2020
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

medroxyprogestrone acetate

Outcome Measures

Primary Outcomes (1)

• complete response rate

  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 Outcomes (3)

• disease-free survival

  every 3 months during 24 months from time of obtaining complete response

• fertility outcomes

  every 3 months during 24 months from time of obtaining complete response

• Side effects of MPA, dosage of 50mg/day

  From date of starting of MPA until the study end assessed up to 36 months

Study Arms (1)

Single group

EXPERIMENTAL

Farlutal tab. 500mg/ Pfizer to be administered

Drug: Farlutal tab. 500mg/ Pfizer

Interventions

Farlutal tab. 500mg/ Pfizer DRUG

Medroxyprogesterone Acetate

Single group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Korean Gynecologic Oncology Group: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (4)

• 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.

  PMID: 25673106 BACKGROUND

• 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.

  PMID: 3972284 BACKGROUND

• 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.

  PMID: 5643760 BACKGROUND

• Skouby SO. The rationale for a wider range of progestogens. Climacteric. 2000 Dec;3 Suppl 2:14-20.

  PMID: 11379382 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yong-Man Kim, MD Ph.D.

  Korean Gynecologic Oncologic Group

  STUDY CHAIR

Central Study Contacts

Jeong-yeol Park, MD Ph.D.

CONTACT

82-2-3010-3646; objyjypark@amc.seoul.kr

Dae-Yeon Kim, MD Ph.D.

CONTACT

82-2-3010-3748; kdyog@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Model Details: This study is a single arm, prospective multi-institutional study.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: June 26, 2018
• Study Start: July 15, 2018
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)