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 groups

Locations

19
Ospedale San Donato52100, ArezzoAR, Italy
Ospedale degli Infermi13875, PonderanoBI, Italy
Ospedale San Martino32100, BellunoBL, Italy
ASST degli Spedali Civili di Brescia BresciaBS, Italy

Sponsors and collaborators

Ente Ospedaliero Ospedali Galliera

Lead sponsor

Istituto Di Ricerche Farmacologiche Mario Negri

Collaborator

Humanitas Hospital, Italy

Collaborator