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MD",{"type":35,"investigatorFullName":167,"investigatorTitle":286,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Medical Oncology Director",[288,290],{"name":289,"class":6},"Istituto Di Ricerche Farmacologiche Mario Negri",{"name":291,"class":6},"Humanitas Hospital, Italy","100485486",false,"NCT05601700","Letrozole for Estrogen\u002FProgesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)","Letrozole for Estrogen\u002FProgesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)","LEPRE","Inclusion Criteria:\n\nI - 1. Age ≥ 18 years. I - 2. 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.\n\nI - 3. Immunohistochemically determined positivity (≥ 10%) for ER and\u002For PgR expression. This is to be confirmed by centralized review.\n\nI - 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.\n\nI - 5. Stage III-IV according to 2018 FIGO classification. For proper staging:\n\n* 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\u002FCT-scan are allowed.\n* The imaging evaluation must be accompanied by an anamnestic and physical examination within 14 days prior to randomization.\n\nI - 6. Postmenopausal, defined as any of the following criteria:\n\n* Patients who underwent bilateral salpingo-oophorectomy;\n* Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years;\n* Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months, age \\\u003C60 years and FSH and serum estradiol levels within the laboratory's reference ranges for post-menopausal women.\n\nI - 7. Randomization must take place within 60 days of primary cytoreductive surgery.\n\nI - 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1.\n\nI - 9. To be able to take oral medications.\n\nI - 10. Adequate bone marrow, hepatic and renal functions as defined below:\n\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n* Platelets ≥ 100,000\u002Fmm3\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN)\n* ALT and AST ≤ 3.0 x ULN\n* Alkaline phosphatase ≤ 2.5 x ULN\n* Albumin ≥ 2.8 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN.\n\nI - 11. Written informed consent obtained prior to any study-specific procedure.\n\nExclusion Criteria:\n\nE - 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated.\n\nE - 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.\n\nE - 3. Previous hormonal therapy for the treatment of this disease.\n\nE - 4. Known hypersensitivity to letrozole or known hypersensitivity\u002Fintolerance to carboplatin\u002Fpaclitaxel therapy.\n\nE - 5. Active or uncontrolled systemic infection.\n\nE - 6. Known central nervous system metastases.\n\nE - 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization.\n\nE - 8. New York Heart Association (NYHA) Class III or greater congestive heart failure.\n\nE - 9. Neuropathy grade 2 or higher.\n\nE - 10. History of fractures of the spine or femur not properly treated.\n\nE - 11. 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.\n\nE - 12. 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.\n\nE - 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.","FEMALE","18 Years",{"count":302,"type":303},132,"ESTIMATED","INTERVENTIONAL",[306],"PHASE3","This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO).\n\nThe hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg\u002Fm2.",[309,310],"Carcinoma, Ovarian Epithelial","Low Grade Serous Adenocarcinoma of Ovary",[312,313,314],"Estrogen\u002Fprogesteron receptor positive tumor","Letrozole","Aromatase Inhibitors","2025-01-23",{"date":317,"type":318},"2025-01-27","ACTUAL",{"date":320,"type":318},"2022-09-22",{"date":322,"type":303},"2029-09-22",{"name":5,"class":6},19]