RecruitingPhase 3NCT05601700
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)
Sponsor
Ente Ospedaliero Ospedali Galliera
Enrollment
132 participants
Start Date
Sep 22, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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). The 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/m2.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria23
- I - 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.
- I - 3. Immunohistochemically determined positivity (≥ 10%) for ER and/or PgR expression. This is to be confirmed by centralized review.
- I - 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.
- I - 5. Stage III-IV according to 2018 FIGO classification. For proper staging:
- 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.
- I - 6. 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 FSH and serum estradiol levels within the laboratory's reference ranges for post-menopausal women.
- I - 7. Randomization must take place within 60 days of primary cytoreductive surgery.
- I - 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1.
- I - 9. To be able to take oral medications.
- I - 10. 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.
- I - 11. Written informed consent obtained prior to any study-specific procedure.
Exclusion Criteria13
- E - 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated.
- E - 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
- E - 3. Previous hormonal therapy for the treatment of this disease.
- E - 4. Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy.
- E - 5. Active or uncontrolled systemic infection.
- E - 6. Known central nervous system metastases.
- E - 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization.
- E - 8. New York Heart Association (NYHA) Class III or greater congestive heart failure.
- E - 9. Neuropathy grade 2 or higher.
- E - 10. History of fractures of the spine or femur not properly treated.
- E - 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.
- E - 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.
- E - 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.
Interventions
DRUGLetrozole tablets
ATC: L02BG04
DRUGcarboplatin AUC 5 and paclitaxel 175 mg/m2
ATC: L01XA02 and ATC: L01CD01 respectively
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT05601700