Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Megestrol Acetate 160 MG Oral Tablet
- Medroxyprogesterone Acetate 500 MG
- Triprorelin Acetate
- Letrozole 2.5mg
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fudan University
Lead sponsor
Peking Union Medical College Hospital
Collaborator
Source ClinicalTrials.gov