Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer

Endometrial Neoplasm Malignant Stage I Clinical Trial

Official title:

Megestrol Acetate Plus LNG-IUS to Megestrol Acetate in Young Women With Early Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241914
• Other study ID #: 2017-30-2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 4, 2017
• Est. completion date: June 18, 2020

Study information

• Verified date: November 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patients with early endometrial cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Neoplasm Malignant Stage I
• Endometrial Neoplasms
• Neoplasms

Intervention

Drug:
• Megestrol Acetate
At a dosage of 160 mg/day

Device:
• Levonorgestrel-releasing Intrauterine System(LNG-IUS)
levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic consequences through study completion	The investigators will evaluate whether the combination could shorten therapeutic period, so that bring economic benefits to the patients.	From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
Primary	Pathological response rate		From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
Primary	Pathological response time	median time of histologic regression from endometrial atypical hyperplasia to benign endometrium	From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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
Secondary	Rate of relapse		up to 2 years after the treatment for each patient
Secondary	Rate of pregnancy		up to 2 years after the treatment for each patient
Secondary	Compliance	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.	up to 2 years after the treatment for each patient