Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
NCT ID: NCT03241914
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2017-07-04
2020-06-18
Brief Summary
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Detailed Description
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Patients are randomized to 1 of 2 treatment groups. Patients will receive MA (megestrol acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive MA 160 mg plus LNG-IUS insertion for at least 3 months on Arm II. Then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. For patients with EEC, complete response (CR) is defined as the reversion of endometrial disease to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypic or atypical hyperplasia; no response (NR) 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, NR or PD.
As the reason of the low response rate of LNG-IUS alone in EC patients (nearly 50%), and the potential limitation of LNG-IUS to focal cancer lesion in endometrial cavity, the investigators did not add LNG-IUS alone as a single control group.
After completion of study treatment, 2 months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MA
Patients will receive megestrol acetate 160 mg by mouth daily for at least 3 months.Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
Megestrol Acetate
At a dosage of 160 mg/day
MA+LNG-IUS
Patients will receive MA (160mg po qd) plus LNG- IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
Megestrol Acetate
At a dosage of 160 mg/day
Levonorgestrel-releasing Intrauterine System(LNG-IUS)
levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Interventions
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Megestrol Acetate
At a dosage of 160 mg/day
Levonorgestrel-releasing Intrauterine System(LNG-IUS)
levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
* Have a desire for remaining reproductive function or uterus
* Need to be able to undergo correlative treatment and follow-up
Exclusion Criteria
* Pregnancy or suspicion of pregnancy
* Have a history of EAH or EC and have disease relapse during Merina insertion
* Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
* Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* Confirmed diagnosis of malignant tumor in genital system
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* Hypersensitivity or contradiction to any component of this product
* Ask for removal of the uterus or other conservative treatment
* Smoker(\>15 cigarettes a day)
18 Years
45 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaojun Chen
Principal Investigator
Locations
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Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Xu Z, Yang B, Guan J, Shan W, Liao J, Shao W, Chen X. Comparison of the effect of oral megestrol acetate with or without levonorgestrel-intrauterine system on fertility-preserving treatment in patients with early-stage endometrial cancer: a prospective, open-label, randomized controlled phase II trial (ClinicalTrials.gov NCT03241914). J Gynecol Oncol. 2023 Jan;34(1):e32. doi: 10.3802/jgo.2023.34.e32. Epub 2022 Dec 15.
Other Identifiers
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2017-30-2
Identifier Type: -
Identifier Source: org_study_id