- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241914
Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
Megestrol Acetate Plus LNG-IUS to Megestrol Acetate in Young Women With Early Endometrial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After diagnosed of endometrioid endometrial cancer (EEC) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before treatment to evacuate their metabolic conditions.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200011
- Obstetrics and Gynecology Hospital, Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primarily have a confirmed diagnosis of endometrioid endometrial cancer based upon hysteroscopy
- 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:
- Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
At a dosage of 160 mg/day
Other Names:
|
Experimental: 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.
|
At a dosage of 160 mg/day
Other Names:
levonorgestrel 52mg.
It is a hormone-releasing T-shaped intrauterine system.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological response rate
Time Frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
|
From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
|
|
Pathological response time
Time Frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
|
median time of histologic regression from endometrial atypical hyperplasia to benign endometrium
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From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 2 years after the treatment for each patient
|
Common side effects from these drugs include weight gain, vaginal spotting and descent of sexuality.
Severe side effects include thrombus and diseases related.
The investigators will record any mental or body symptoms and evaluate the correlation.
|
up to 2 years after the treatment for each patient
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Rate of relapse
Time Frame: up to 2 years after the treatment for each patient
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up to 2 years after the treatment for each patient
|
|
Rate of pregnancy
Time Frame: up to 2 years after the treatment for each patient
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up to 2 years after the treatment for each patient
|
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Compliance
Time Frame: up to 2 years after the treatment for each patient
|
The investigators designed a questionnaire to evaluate the compliance through treatment as side effects of oral megestrol acetate may be more common than LNG-IUS.
Self Efficacy, physical activity and social support will be scored (1 to 5) and compared between different arms.
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up to 2 years after the treatment for each patient
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Economic consequences through study completion
Time Frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
|
The investigators will evaluate whether the combination could shorten therapeutic period, so that bring economic benefits to the patients.
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From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Neoplasms
- Endometrial Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Levonorgestrel
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 2017-30-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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