Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
NCT ID: NCT05247268
Last Updated: 2025-04-06
Study Results
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Basic Information
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RECRUITING
PHASE2
104 participants
INTERVENTIONAL
2022-03-11
2027-09-10
Brief Summary
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Detailed Description
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Hysteroscopy will be performed every 3 months during treatment to evaluate the treatment effects. For patients with EEC, complete response (CR) is defined as the reversion of endometrial carcinoma to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia with or without atypia; Stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions. Continuous therapies will be needed in PR, SD or PD.The primary endpoint was cumulative complete response (CR) rate at 16 weeks of treatment. The secondary endpoints were cumulative CR rate at 28weeks of treatment, adverse events, recurrent rate, pregnancy rate, effects on ovarian function and quality of life of patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GnRHa+letrozole
Patients will be stratified into BMI≥28kg/m2 group and BMI\<28kg/m2 group. Patients in BMI≥28kg/m2 or BMI\<28kg/m2 group will be randomly assigned (1:1) to GnRHa+letrozole group or MA/MPA group. Patients who will be assigned to GnRHa+letrozole group will receive triprorelin acetate (intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses) plus letrozole (2.5mg oral daily and no more than 24 weeks). Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
Triprorelin Acetate
Intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses
Letrozole 2.5mg
At a dosage of 2.5mg/day and no more than 24 weeks
MA/MPA
Patients will be stratified into BMI≥28kg/m2 group and BMI\<28kg/m2 group. Patients in BMI≥28kg/m2 or BMI\<28kg/m2 group were randomly assigned (1:1) to GnRHa+letrozole group or MA/MPA group.Patients assigned to MA/MPA group will receive MA/MPA (160 mg oral MA daily or 500 mg oral MPA daily).Then every 3 months, an hysteroscopy will be used to evaluate the endometrial condition, and the findings will be recorded.
Megestrol Acetate 160 MG Oral Tablet
At a dosage of 160 mg/day
Medroxyprogesterone Acetate 500 MG
At a dosage of 500 mg/day
Interventions
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Megestrol Acetate 160 MG Oral Tablet
At a dosage of 160 mg/day
Medroxyprogesterone Acetate 500 MG
At a dosage of 500 mg/day
Triprorelin Acetate
Intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses
Letrozole 2.5mg
At a dosage of 2.5mg/day and no more than 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
45 Years
FEMALE
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Xiaojun Chen
Prof.Dr.
Locations
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Obstetrics and Gynecology Hospital, Fudan University
Shanghai, , China
Countries
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Facility Contacts
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References
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Zhou H, Cao D, Yang J, Shen K, Lang J. Gonadotropin-Releasing Hormone Agonist Combined With a Levonorgestrel-Releasing Intrauterine System or Letrozole for Fertility-Preserving Treatment of Endometrial Carcinoma and Complex Atypical Hyperplasia in Young Women. Int J Gynecol Cancer. 2017 Jul;27(6):1178-1182. doi: 10.1097/IGC.0000000000001008.
Rackow BW, Arici A. Endometrial cancer and fertility. Curr Opin Obstet Gynecol. 2006 Jun;18(3):245-52. doi: 10.1097/01.gco.0000193012.11523.c5.
Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9. doi: 10.1002/cncr.21650.
Corzo C, Barrientos Santillan N, Westin SN, Ramirez PT. Updates on Conservative Management of Endometrial Cancer. J Minim Invasive Gynecol. 2018 Feb;25(2):308-313. doi: 10.1016/j.jmig.2017.07.022. Epub 2017 Aug 3.
Gressel GM, Parkash V, Pal L. Management options and fertility-preserving therapy for premenopausal endometrial hyperplasia and early-stage endometrial cancer. Int J Gynaecol Obstet. 2015 Dec;131(3):234-9. doi: 10.1016/j.ijgo.2015.06.031. Epub 2015 Sep 8.
Baek JS, Lee WH, Kang WD, Kim SM. Fertility-preserving treatment in complex atypical hyperplasia and early endometrial cancer in young women with oral progestin: Is it effective? Obstet Gynecol Sci. 2016 Jan;59(1):24-31. doi: 10.5468/ogs.2016.59.1.24. Epub 2016 Jan 15.
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Chen M, Jin Y, Li Y, Bi Y, Shan Y, Pan L. Oncologic and reproductive outcomes after fertility-sparing management with oral progestin for women with complex endometrial hyperplasia and endometrial cancer. Int J Gynaecol Obstet. 2016 Jan;132(1):34-8. doi: 10.1016/j.ijgo.2015.06.046. Epub 2015 Oct 1.
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Minig L, Franchi D, Boveri S, Casadio C, Bocciolone L, Sideri M. Progestin intrauterine device and GnRH analogue for uterus-sparing treatment of endometrial precancers and well-differentiated early endometrial carcinoma in young women. Ann Oncol. 2011 Mar;22(3):643-649. doi: 10.1093/annonc/mdq463. Epub 2010 Sep 28.
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Other Identifiers
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53211032
Identifier Type: -
Identifier Source: org_study_id
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