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Trial Title:
GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients
NCT ID:
NCT06379113
Condition:
Endometrial Neoplasms
Atypical Endometrial Hyperplasia
Progesterone Resistance
Obesity
Conditions: Official terms:
Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Letrozole
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GnRH antagonist
Description:
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.
Arm group label:
Obese EEC group
Intervention type:
Drug
Intervention name:
Letrozole 2.5mg
Description:
2.5mg po qd.
Arm group label:
Obese EEC group
Summary:
To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC
patients.
Detailed description:
There were more and more women with early endometrioid endometrial cancer (EEC) and
atypical endometrial hyperplasia (EAH) who want to preserve fertility.
Approximately 70% to 80% of females who meet the criteria for conservation treatment are
able to achieve CR after progestin therapy, with a median time of 6-7 months, but about
20% to 30% of patients get no response or need to take longer time to achieve remission
(over one year). With long duration of treatment, there will be more side effects such as
weight gain, impaired liver function, endometrial injury, ovarian reserve inhibition etc.
which will decrease the efficacy of conservative treatment. Previous researches had shown
that GnRHa plus letrozole could be a better second-line treatment for obese
progestin-insensitive patients. Till now, no similar studies were found, so we design
this study to explore the efficacy of GnRHa plus letrozole in obese progestin-insensitive
EEC and EAH patients to provide new evidences for improving conservative treatment
efficacy. We defined obese patients as these with BMI ≥ 30kg/m2.
This will be a single-centred prospective pilot study. Patients diagnosed as obese
progestin-insensitive EEC by dilatation and curettage (D&C) or hysteroscopy will be
enrolled. The primary endpoint is cumulative complete response (CR) rate at 28 weeks of
treatment. The secondary endpoints include adverse events, duration of complete response,
recurrent rate, pregnancy rate and quality of life of patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine
System (LNG-IUS) inserted or not
2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted
or not
3. LNG-IUS inserted
- Progestin-insensitive:
1. remained with stable disease after 7 months of progestin use
2. 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 Criteria:
- 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tenth People's Hospital of Tongji University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Weina Wang
Phone:
8602166300588
Email:
wangweinals@163.com
Facility:
Name:
Obstetrics and Gynecology Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojun Chen
Phone:
862133189900
Email:
cxjlhjj@163.com
Start date:
July 13, 2022
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Xiaojun Chen
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06379113
