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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03567655
• Other study ID #: KGOG 2020
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 15, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2018
• Source: Asan Medical Center
• Contact: Jeong-yeol Park, MD Ph.D.
• Phone: 82-2-3010-3646
• Email: objyjypark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 41
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• Farlutal tab. 500mg/ Pfizer
Medroxyprogesterone Acetate

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korean Gynecologic Oncology Group

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

Kempson RL, Pokorny GE. Adenocarcinoma of the endometrium in women aged forty and younger. Cancer. 1968 Apr;21(4):650-62. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	disease-free survival	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
Secondary	fertility outcomes	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
Secondary	Side effects of MPA, dosage of 50mg/day	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