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

NCT03241914CompletedPHASE2, PHASE3INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Fudan University

Enrollment

64

Start Date

2017-07-04

Completion Date

2020-06-18

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Megestrol AcetateLevonorgestrel-releasing Intrauterine System(LNG-IUS)

Conditions

Endometrial Neoplasm Malignant Stage I

Eligibility

Age Range

18 Years – 45 Years

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

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

Pathological response time

median time of histologic regression from endometrial atypical hyperplasia to benign endometrium

Time frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Secondary Outcomes

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.

Time frame: up to 2 years after the treatment for each patient

Rate of relapse

Time frame: 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

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.

Time frame: up to 2 years after the treatment for each patient

Locations

Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China

Linked Papers

2022-12-15

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)

To evaluate the effect of levonorgestrel-releasing intrauterine system (LNG-IUS) plus oral megestrol acetate (MA) as fertility-preserving treatment in patients with early-stage endometrial cancer (EEC). In this single-center, phase II study with open-label, randomized and controlled design, young patients (18-45 years) diagnosed with primary EEC were screened, who strongly required fertility-preserving treatment. Patients were randomly assigned (1:1) into MA group (160 mg oral daily) or MA (160 mg oral daily) plus LNG-IUS group. Pathologic evaluation on endometrium retrieved by hysteroscopy was performed every 3 months. The primary endpoint was complete response (CR) rate within 16 weeks of treatment. The secondary endpoints were CR rate within 32 weeks of treatment, adverse events, recurrent and pregnancy rate. Between July 2017 and June 2020, 63 patients were enrolled and randomly assigned. Totally 56 patients (26 in MA group; 28 in MA + LNG-IUS group) were included into primary-endpoint analyses. The median follow-up was 31.6 months (range, 3.1-94.0). No significant difference in 16-week CR rate were found between MA and MA + LNG-IUS groups (19.2% vs. 25.0%, p=0.610; odds ratio=1.40; 95% confidence interval=0.38-5.12), while the 32-week CR rates were also similar (57.1% and 61.5%, p=0.743), accordingly. More women in MA + LNG-IUS group experienced vaginal hemorrhage (46.4% vs. 16.1%; p=0.012) compared with MA group. No intergroup difference was found regarding recurrence or pregnancy rate. Compared with MA alone, the addition of LNG-IUS may not improve the early CR rate for EEC, and may produce more adverse events instead. ClinicalTrials.gov Identifier: NCT03241914.

Linked Investigators

Bingyi Yang

Jiongbo Liao

Jun Guan

Weiwei Shan

Wenyu Shao

Xiaojun Chen

Zhiying Xu

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