Phase III Study Comparing Letrozole and Standard Chemotherapy for Advanced Low-grade Serous Epithelial Ovarian Cancer with Hormone Receptor Positivity

What this Trial Is About

Researchers are evaluating whether letrozole is more effective than standard chemotherapy for treating patients with hormone receptor positive low-grade serous epithelial ovarian carcinoma LGSCO. This phase III, open-label, randomized trial aims to see if letrozole can extend progression-free survival compared to carboplatin and paclitaxel chemotherapy. The study also explores tumor response, quality of life, pain, overall survival, safety, and genetic markers related to the disease. Participants will be randomly assigned to one of two groups one group takes letrozole tablets daily by mouth for up to 60 months or until disease progression, while the other group receives carboplatin and paclitaxel intravenously on day 1 every 21 days for 6 to 8 cycles. The treatments are compared directly to assess their effects on cancer control and patient well-being. During the study, participants will have regular assessments including tumor response evaluations, quality of life questionnaires, pain inventory, and safety monitoring according to standard criteria. Genetic profiling and circulating tumor DNA will be analyzed to understand disease characteristics. Progression-free survival will be tracked for up to 84 months, with ongoing monitoring of overall survival and adverse events. Participants will be followed closely to observe treatment effects and side effects throughout the trial period.

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