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New treatment option for Carcinoma, Ovarian Epithelial
Official title Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
ClinicalTrials.gov ID: NCT05601700
What this study is testing
What is Letrozole tablets?
Letrozole tablets is an investigational medicine, being studied as a potential treatment for carcinoma, ovarian epithelial.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- I - 1. Age ≥ 18 years. I - 2. Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive...
- 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...
- The imaging evaluation must be accompanied by an anamnestic and physical examination within 14 days prior to randomization. I - 6. Postmenopausal...
- Patients who underwent bilateral salpingo-oophorectomy;
- Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years;
You likely can't join if
- 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.
See the full eligibility 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)...
- 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...
- 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...
- 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.
- 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...
- E - 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.
The study team makes the final eligibility decision.
Where it's taking place
- Arezzo, AR, Italy
- Ponderano, BI, Italy
- Belluno, BL, Italy
- Brescia, BS, Italy
- Como, CO, Italy
- Meldola, FC, Italy
- Ferrara, FE, Italy
- Genova, Genova, Italy
- Milan, MI, Italy
- Padua, PD, Italy
- Roma, RM, Italy
- Castelfranco Veneto, TV, Italy
- Treviso, TV, Italy
- Varese, VA, Italy
- Rimini, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arezzo, AR, Italy; Ponderano, BI, Italy; Belluno, BL, Italy; Brescia, BS, Italy; Como, CO, Italy; Meldola, FC, Italy and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.