NCT05601700 Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
| NCT ID | NCT05601700 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ente Ospedaliero Ospedali Galliera |
| Condition | Carcinoma, Ovarian Epithelial |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2022-09-22 |
| Primary Completion | 2029-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 132 participants in total. It began in 2022-09-22 with a primary completion date of 2029-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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 Criteria: 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.
Contact & Investigator
Andrea DeCensi, MD
PRINCIPAL INVESTIGATOR
E.O.Ospedali Galliera
Frequently Asked Questions
Who can join the NCT05601700 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Carcinoma, Ovarian Epithelial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05601700 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 132 participants.
Is NCT05601700 currently recruiting?
Yes, NCT05601700 is actively recruiting participants. Contact the research team at andrea.decensi@galliera.it for enrollment information.
Where is the NCT05601700 trial being conducted?
This trial is being conducted at Arezzo, Italy, Ponderano, Italy, Belluno, Italy, Brescia, Italy and 11 additional locations.
Who is sponsoring the NCT05601700 clinical trial?
NCT05601700 is sponsored by Ente Ospedaliero Ospedali Galliera. The principal investigator is Andrea DeCensi, MD at E.O.Ospedali Galliera. The trial plans to enroll 132 participants.