Phase II Study of Surgery and Niraparib Maintenance for Women with Platinum-Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of cytoreductive surgery combined with Niraparib maintenance therapy compared to chemotherapy followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer. This Phase II, randomized, open-label trial is conducted across multiple centers and includes patients with different histories of PARP inhibitor use and secondary cytoreductive surgery at first recurrence. Participants are assigned to one of two groups one receiving maximum effort cytoreductive surgery followed by platinum-based chemotherapy and Niraparib maintenance, and the other receiving platinum-based chemotherapy and Niraparib maintenance without surgery. The trial includes three cohorts based on prior treatments those without prior PARP inhibitor use or secondary surgery, those with prior PARP inhibitor use but no secondary surgery, and those who had secondary surgery but no prior PARP inhibitor use. Throughout the study, participants will be monitored for disease progression up to 12 months after the last patient is randomized, with additional observations for progression-free survival, treatment-free survival, overall survival, post-operative complications, and quality of life assessments at baseline, 6 months, and 12 months. The study will involve imaging assessments and evaluations by experienced surgeons to determine the possibility of complete resection, with follow-up lasting up to 24 months after randomization.

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)