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Clinical trial

Gonadotropin-releasing Hormone Agonist Combined With Letrozole Compared With Megestrol Acetate or Medroxyprogesterone Acetate Alone as Fertility-sparing Treatment in Early Endometrial Cancer

ID
Name
53211032
Description
To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.
Trial arms
Trial start
2022-03-11
Estimated PCD
2025-03-10
Trial end
2025-03-10
Status
Recruiting
Phase
Early phase I
Treatment
Megestrol Acetate 160 MG Oral Tablet
At a dosage of 160 mg/day
Arms:
MA/MPA
Other names:
Megestrol Acetate
Medroxyprogesterone Acetate 500 MG
At a dosage of 500 mg/day
Arms:
MA/MPA
Other names:
Medroxyprogesterone Acetate
Triprorelin Acetate
Intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses
Arms:
GnRHa+letrozole
Letrozole 2.5mg
At a dosage of 2.5mg/day and no more than 24 weeks
Arms:
GnRHa+letrozole
Other names:
Letrozole
Size
104
Primary endpoint
Complete response rates within 16 weeks of treatment
From date of treatment initiation until the date of CR, assessed up to 16 weeks.
Eligibility criteria
Inclusion Criteria: * Consent informed and signed * Primarily have a confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial inva- sion) ) based upon endometrial biopsy, diagnostic curettage or hysteroscopy * No signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS) * Have a strong desire for remaining reproductive function or uterus * Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time Exclusion Criteria: * Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis * Recurrent endometrial cancer * Combined with severe medical disease or severely impaired liver and kidney function * Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone * Those who require hysterectomy or other methods other than conservative treatment with drugs * Known or suspected pregnancy * Contraindication for Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate, Letrozole or pregnancy * Hormone treatment within 3 months before entering the trial; * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * Smoker(\>15 cigarettes a day)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}
Updated at
2024-04-23

1 organization

4 products

1 indication

Organization
Fudan University
Product
Megestrol Acetate
Indication
Endometrial Cancer Stage I
Product
Medroxyprogesterone Acetate
Product
Triprorelin
Product
Letrozole