Endometrial Neoplasms Clinical Trial
Official title:
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment
Verified date | April 2024 |
Source | Fudan University |
Contact | Xiaojun Chen, PhD |
Phone | 8602133189900 |
cxjlhjj[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 30, 2025 |
Est. primary completion date | March 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or 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 Diane-35, GnRHa, Letrozole or MET - 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) |
Country | Name | City | State |
---|---|---|---|
China | Obstetrics and Gynecology Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xiaojun Chen |
China,
Zhou S, Xu Z, Yang B, Guan J, Shan W, Shi Y, Chen X. Characteristics of progestin-insensitive early stage endometrial cancer and atypical hyperplasia patients receiving second-line fertility-sparing treatment. J Gynecol Oncol. 2021 Jul;32(4):e57. doi: 10.3802/jgo.2021.32.e57. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete response rates within 28 weeks of treatment | The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment. | From date of randomization until the date of CR, assessed up to 28 weeks | |
Secondary | Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events. | From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks | |
Secondary | Time to achieve complete response | The median CR time will be calculated in two groups | From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks. | |
Secondary | Relapse rates | Up to 2 years after the treatment | ||
Secondary | Rates of fertility outcomes | Including pregnancy and live-birth rates | Up to 2 years after the treatment | |
Secondary | Compliance | Data on treatment and hysteroscopy management will be collected, and deviations from study protocol will be recorded in writing. For example, the time of drug interruptions due to related toxicities or AEs, and delay of hysteroscopy for personal reasons. |
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