2024-516874-31-00招募中3 期
Letrozole for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer. A randomized phase III trial. LEPRE Trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 35
- 主要终点
- The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first.
研究概览
简要总结
The primary objective is to determine if letrozole is superior to standard chemotherapy in terms of progression-free survival (PFS) in patients with advanced low-grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma). This is to be confirmed via nuclear p53 immunohistochemistry testing by a central pathology review performed at the Coordinating Centre.
- •Immunohistochemically determined positivity (≥ 10%) for PgR and/or ER expression. This is to be confirmed by centralized review.
- •Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.
- •Stage III-IV according to 2018 FIGO classification. Furthermore, for a proper baseline evaluation patients must have undergone contrast-enhanced CT-scan of the chest, abdomen and pelvis within 28 days prior to randomization. If CT-scan is not recommended (e.g. for allergy to contrast agent) MRI or 18F-FDG PET/CT-scan are allowed. The imaging evaluation must be accompanied by an anamnestic and physical examination within 14 days prior to randomization.
- •Postmenopausal, defined as any of the following criteria: - Patients who underwent bilateral salpingo-oophorectomy; - Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years; - Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months, age <60 years and plus FSH and serum estradiol levels within the laboratory’s reference ranges for postmenopausal women.
- •Randomization must take place within 90 days (preferably within 60 days) of primary cytoreductive surgery.
- •Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-
- •To be able to take oral medications
- •Adequate bone marrow, hepatic and renal functions as defined below: - Absolute neutrophil count (ANC) ≥ 1500/mm3 - Platelets ≥ 100,000/mm3 - Hemoglobin ≥ 10.0 g/dL - Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) - ALT and AST ≤ 3.0 x ULN - Alkaline phosphatase ≤ 2.5 x ULN - Albumin ≥ 2.8 g/dL - Serum creatinine ≤ 1.5 x ULN.
- •Written informed consent obtained prior to any study-specific procedure.
排除标准
- •Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated.
- •Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
- •Previous hormonal therapy for the treatment of this disease.
- •Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy.
- •Active or uncontrolled systemic infection.
- •Known central nervous system metastases.
- •Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization.
- •New York Heart Association (NYHA) Class III or greater congestive heart failure.
- •Neuropathy grade 2 or higher.
- •History of fractures of the spine or femur not properly treated.
- •Known osteoporosis (dual-energy x-ray absorptiometry (DEXA) of the femoral neck T score of −2.5 or lower) not adequately treated with bisphosphonates or RANKL inhibitors.
- •Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John’s Wort) which may reduce exposure to letrozole. Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole.
- •Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.
结局指标
主要结局
The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first.
The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first.
次要结局
- Objective Response Rate (ORR), defined as the percentage of patients with an objective response determined by a complete response (CR) or a partial response (PR) as determined by RECIST 1.1.
研究者
Head of Oncology Division and Medicine Department
Scientific
Ente Ospedaliero Ospedali Galliera Di Genova
研究点 (35)
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