A Phase II Head-to-Head Comparison of Fertility-Sparing Approaches to Treat Complex Atypical Hyperplasia of the Edometrium: Megestrol Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Histologic regression from endometrioid adenocarcinoma or complex atypical hyperplasia to benign endometrium
研究概览
简要总结
This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the levonorgestrel-releasing intrauterine system (IUS) results in histologic regression of the endometrial lesion (complex atypical hyperplasia [CAH] and grade 1 endometrial cancer [EC]) comparable to that achieved with oral megestrol (megestrol acetate).
SECONDARY OBJECTIVES:
I. To compare both the side effect profiles, such as weight gain and mood changes as well as compliance with assigned treatment between the 2 treatment arms.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A histologic diagnosis of complex atypical hyperplasia or grade 1 endometrioid adenocarcinoma of the endometrium diagnoses within 3 months of study enrollment who strongly desire to maintain fertility
- •A diagnosis of endometrioid adenocarcinoma will undergo a magnetic resonance imaging (MRI) scan of the pelvis to rule out deep (> 50%) myometrial invasion and extrauterine metastases
- •A negative urine or serum pregnancy test at the time of enrollment
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •Willing and able to consent for treatment with office endometrial biopsies every 3 months
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •A diagnosis of grade 1 endometrioid adenocarcinoma of the endometrium who does not wish to maintain fertility
- •MRI evidence of deep myometrial and/or extrauterine spread
- •Congenital or other structural uterine or tubal abnormality
- •An acute pelvic inflammatory disease or medical conditions, such as, but not limited to acquired immunodeficiency syndrome (AIDS) and chronic immunosuppression, that may be associated with an increased susceptibility to infections
- •Current diagnosis of breast cancer or any other cancer
- •Currently pregnant or breastfeeding
- •Thromboembolic disease, deep vein thrombosis, hypercoagulable state
研究组 & 干预措施
Arm A (megestrol acetate)
Patients receive megestrol acetate PO BID for up to 18 months in the absence of disease progression or unacceptable toxicity.
干预措施: megestrol acetate (Drug)
Arm A (megestrol acetate)
Patients receive megestrol acetate PO BID for up to 18 months in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm A (megestrol acetate)
Patients receive megestrol acetate PO BID for up to 18 months in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Arm B (levonorgestrel-releasing IUS)
Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.
干预措施: levonorgestrel-releasing intrauterine system (Device)
Arm B (levonorgestrel-releasing IUS)
Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm B (levonorgestrel-releasing IUS)
Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Histologic regression from endometrioid adenocarcinoma or complex atypical hyperplasia to benign endometrium
时间窗: Up to 6 months after completion of study treatment
Histologic regression will be dichotomized as a binary outcome variable, yes if patients have a confirmed histologic regression at the time of the scheduled biopsy, and no if the histologic regression is not observed regardless of compliance, lost-to-follow-up, or other issues. A contingency table and a bar plot will be used to show the histologic regression rate between the 2 arms. Two-group test of equivalence in proportions will be used to detect whether the histologic regression rate in Arm B is not significantly lower than that in Arm A.
次要结局
- Change in weight(Baseline to up to 6 months after completion of study treatment)
- Change in mood ascertained using the self-reported Beck Depression Inventory-Primary Care (BDI-PC)(Baseline to up to 6 months after completion of study treatment)
- Compliance(Up to 6 months after completion of study treatment)