Safety and Efficacy study of repeated MPA therapy for recurrent early stage endometrial cancer patients (JGOG2051)

JRCT ID: jRCTs031200256

Registered date:21/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early stage endometrial cancer and atypical endometrial hyperplasia.
• Date of first enrollment: 15/01/2021
• Target sample size: 115
• Countries of recruitment: Korea,Japan
• Study type: Interventional
• Intervention(s): Medroxyprogesterone acetate (MPA)

Outcome(s)

• Primary Outcome: 2-year recurrence free survival rate

Secondary Outcome

Progression free survival
Overall survival
Complete response rate
Pregnancy rate
Adverse event
Number of dilation and curettage
Hysterectomy rate
Infertility treatment rate and procedure
Perinatal and pregnancy prognosis
Family history of cancer

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 42age 11month old
• Gender: Female

Include criteria

1) Patients with atypical endometrial hyperplasia or G1 without myometrial invasion or extrauterine lesions who underwent high-dose MPA therapy for primary lesions or intrauterine recurrence.
Recurrence number can be allowed up to 2 times.
2) Patients with histologically confirmed endometrial carcinoma Grade 1 or endometrial by recent dilation and curettage.
3) Patients without possible myometrial invasion, cervical stromal invasion or extrauterine lesions by pelvic MRI at relapse.
4) Patients without possible lymph node or distant metastases by CT imaging of the chest, abdomen and pelvis at relapse.
5) Age 20 to 42 years old.
6) Patients who hope to preserve fertility.
7) ECOG performance status:0-1
8) The following tests must be conducted within
14 days prior to enrollment:
Neutrophils count more than or equal to 1,000/mm3
Hemoglobin more than or equal to 9.0g/dL
Platelet count more than or equal to 10.0x10000/mm3
AST(GOT), ALT(GPT) less than or equal to 100 U/L
Serum total bilirubin less than or equal to 2.2mg/dL
Serum creatine less than or equal to 1.5mg/dL
D-dimer less than or equal to 1.0ug/mL
9) Signed informed consent obtained prior to initiation of study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.

Exclude criteria

1) Patients without recurrent intrauterine lesions histologically diagnosed endometrial carcinoma Grade 1 or atypical hyperplasia.
2) Recurrent number more than or equal to 3 (*)
3) Patients who have been registered to this trial.
4) Patients without pathologically disappeared intrauterine lesions at previous treatment. Pathological disappearance is defined as disappearance of endometrial hyperplasia.
5) Patients whose myometrium cannot be diagnosed correctly due to uterine disease (such as endometriosis or leiomyoma)by pelvic MRI
6) Patients with a history or evidence of thrombosis
7) BMI more than or equal to 45kg/m2
8) Patients with a history of hypersensitivity to luteinizing hormone.
9) Patients with heart disease (such as valvular heart disease, atrial fibrillation, endocarditis, severe heart failure
10) Peripheral neuropathy (motor and/or sensory) of Grade 2 or greater (CTCAE v 5.0).
11) Patients with active double/multiple cancer, or double cancer patients with disease free interval of less than 5 years (lesions equivalent to carcinoma in situ is excluded as active double cancer).
12) Patients with a history of chemotherapy or radiotherapy.
13) Patients with severe hepatic dysfunction.
14) Patients with hypercalcemia.
15) Patients with poorly controlled diabetes and/or hypertension.
16) Patients who cannot undergo MRI and CT.
17) Patients who cannot stop other hormone therapy
18) Patients who is judged inappropriate to participate in this study by the principle investigator.
* If complete response rate of 2-time recurrent patients is clearly poor, the registration of 2-time recurrent patients will be discontinued.

Related Information

• Primary Sponsor: Yamagami Wataru