El Palmar

Researchers are evaluating the effectiveness of maintenance treatments using niraparib alone versus niraparib combined with bevacizumab in women newly diagnosed with advanced stage IIIA, IIIB, or IIIC high-grade epithelial ovarian cancer who have no visible disease remaining after initial surgery and chemotherapy. This phase II, randomized, open-label multicenter trial aims to compare these approaches following frontline surgery and adjuvant platinum-based chemotherapy with or without bevacizumab. Patients are stratified by BRCA status, cancer stage, and prior hyperthermic intraperitoneal chemotherapy. The study treatments include two groups one receiving carboplatin and paclitaxel chemotherapy over five cycles followed by daily oral niraparib for two years, and the other receiving the same chemotherapy plus bevacizumab for five cycles, then maintenance with both bevacizumab every three weeks for 15 months and daily niraparib for two years. Bevacizumab is administered intravenously starting with the second chemotherapy cycle. The trial investigates the impact of these regimens on progression-free survival and other long-term outcomes. Participants will undergo regular assessments including imaging scans between surgery and chemotherapy to confirm no disease, laboratory tests to monitor organ and bone marrow function, and physical exams during treatment. Researchers will track progression-free survival up to 24 months and other outcomes such as time to subsequent treatments, long-term overall survival, and treatment safety over up to five years. The study involves a total participation period that includes treatment and follow-up evaluations.