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

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).

NCT Number	NCT05659381
Lead Sponsor	GOG Foundation Collaborators: GlaxoSmithKline
Conditions	Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Stage III Primary Peritoneal Cancer, Stage IV Primary Peritoneal Cancer, Stage III Fallopian Tube Cancer, Stage IV Fallopian Tube Cancer
Enrollment	220 participants
Start Date	2024-03-08
Primary Completion	2029-08-01 (estimated)
Study Completion	2034-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-16