RecruitingPhase 2Phase 3NCT06379113
GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment
Sponsor
Xiaojun Chen
Enrollment
29 participants
Start Date
Jul 13, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria12
- Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
- BMI≥30kg/m2
- No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
- Using progestin, any of the following therapy, as first-line treatment:
- Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
- Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
- LNG-IUS inserted
- Progestin-insensitive:
- remained with stable disease after 7 months of progestin use
- did not achieve CR after 10 months of progestin use
- Have a desire for remaining reproductive function or uterus
- Good compliance with adjunctive treatment and follow-up
Exclusion Criteria8
- Combined with severe medical disease or severely impaired liver and kidney function
- Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
- Patients with other types of endometrial cancer or other malignant tumors of the reproductive system
- Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole
- Strong request for uterine removal or other conservative treatment
- Known or suspected pregnancy
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- Smoker(\>15 cigarettes a day)
Interventions
DRUGGnRH antagonist
Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks, and the maximum treatment courses will be 6. If the patient get CR within 6 courses, another 2 courses will be used as consolidation therapy.
DRUGLetrozole 2.5mg
2.5mg po qd.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06379113
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