About this trial
This trial looks at how heated chemotherapy can help patients with advanced ovarian, fallopian tube, and primary peritoneal cancers. Doctors will compare two groups: one group will receive heated intraperitoneal chemotherapy (HIPEC) during surgery, while the other group will not receive HIPEC. After surgery, all patients will receive additional chemotherapy and a maintenance treatment called niraparib. The goal is to see which approach helps keep the cancer under control better after surgery.
The trial's ID number is NCT05659381. It is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. The trial is FDA-regulated and plans to include about 220 participants.
Who can join
This trial is open to adult females aged 18 and older who have a specific type of advanced cancer. Participants must be healthy enough to undergo surgery and have certain test results available before joining. Patients who are pregnant or breastfeeding cannot join. The trial team will check to confirm eligibility.
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
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. One group will receive HIPEC, which includes a heated dose of cisplatin during surgery. The other group will receive no HIPEC and will only have standard surgery. After surgery, all participants will recover and then receive standard chemotherapy followed by niraparib treatment until disease progression or for up to 36 months.
Where
This trial is running at 59 locations in the United States. All of them are currently recruiting.
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania
Baylor College of Medicine Medical Center
Houston, Texas
City of Hope
Duarte, California
Cleveland Clinic
Cleveland, Ohio
Duke Cancer Center
Durham, North Carolina
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina
Forbes Hospital
Monroeville, Pennsylvania
Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin
The first 8 of 59 sites are listed here. The registry record has the full list.