Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEnte Ospedaliero Ospedali Galliera
About this trial
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
Qualifiers
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.
Patients who underwent bilateral salpingo-oophorectomy;
Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years;
Disqualifiers
None
Trial design
Treatments tested in this trial
- Letrozole tablets
- carboplatin AUC 5 and paclitaxel 175 mg/m2
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ente Ospedaliero Ospedali Galliera
Lead sponsor
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborator
Humanitas Hospital, Italy
Collaborator
Source ClinicalTrials.gov