[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-grade-serous-adenocarcinoma-of-ovary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-grade-serous-adenocarcinoma-of-ovary":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100485486","phase-3-letrozole-for-estrogenprogesterone-receptor-positive-low-grade-serous-epithelial-ovarian-cancer-lepre-trial-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":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Carcinoma, Ovarian Epithelial","Low Grade Serous Adenocarcinoma of Ovary",[30,31,32],"Estrogen\u002Fprogesteron receptor positive tumor","Letrozole","Aromatase Inhibitors","RECRUITING","2025-01-23",{"date":36,"type":37},"2025-01-27","ACTUAL",{"date":39,"type":37},"2022-09-22",{"date":41,"type":21},"2029-09-22",{"name":43,"class":44},"Ente Ospedaliero Ospedali Galliera","OTHER",19]