Phase III Study Comparing Heated Cisplatin Chemotherapy During Surgery Followed by Niraparib Maintenance Versus Surgery and Niraparib Alone in Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

What this Trial Is About

This research aims to evaluate the use of heated intraperitoneal chemotherapy HIPEC with cisplatin followed by niraparib maintenance compared to surgery without HIPEC in patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer that is homologous recombinant deficient HRD. The study focuses on patients with stage III or IV disease undergoing neoadjuvant chemotherapy and interval cytoreductive surgery iCRS. It is a phase III randomized trial sponsored by the GOG Foundation to assess progression-free survival and overall survival among these patients. Patients first receive neoadjuvant platinum-based chemotherapy with or without bevacizumab every 21 days for 3 to 4 cycles. After chemotherapy, patients undergo interval cytoreductive surgery aiming for no visible disease or minimal residual disease 1.0 cm. At surgery, participants are randomized to receive either HIPEC with cisplatin 100 mgm2 intraperitoneally over 90 minutes at 42C or no HIPEC. Following recovery, all patients receive additional platinum-based chemotherapy cycles to complete up to six total cycles, followed by maintenance treatment with niraparib, with or without bevacizumab, until disease progression or for up to 36 months if no disease is evident. Throughout the study, participants will be monitored for disease progression, survival, and adverse events for up to 8 years. Assessments include imaging scans and clinical evaluations to measure progression-free survival and overall survival. Safety is monitored regularly with evaluations every 28 days for up to 3 years. Participants blood counts, organ function, and neurological status are assessed to ensure treatment tolerance. The study includes long-term follow-up to evaluate outcomes and safety over an extended period.

Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer