Letrozole Versus Standard Chemotherapy for Hormone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer A Randomized Phase III Trial Evaluating Progression-Free Survival and Treatment Effects

What this Trial Is About

Researchers are evaluating whether letrozole, a hormonal therapy, is more effective than standard chemotherapy in treating women with hormone receptor positive low-grade serous epithelial ovarian carcinoma. This phase III, randomized, open-label trial conducted in Italy aims to see if letrozole can extend the time patients live without their cancer worsening compared to the usual chemotherapy treatment of carboplatin and paclitaxel. The study also investigates effects on tumor response, quality of life, pain, safety, and overall survival, along with genetic profiling and disease monitoring through blood tests. Participants will receive either letrozole tablets or the standard chemotherapy regimen of carboplatin AUC 5 and paclitaxel 175 mg/m2. Treatments are given as first-line therapy after surgery. The study includes detailed assessments of estrogen and progesterone receptor status and requires patients to have had surgery with residual disease status assessed. The trial also includes translational research components analyzing gene mutations and circulating tumor DNA to understand treatment response. During the study, women will be monitored for progression-free survival over a period of 54 to 84 months. Researchers will evaluate tumor response, health-related quality of life using specific questionnaires, pain levels, and safety according to established criteria. Imaging scans, blood tests, and physical exams will be regularly conducted to track disease status. Participants must provide informed consent and will be followed closely to assess long-term outcomes and side effects throughout the trial period.

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)