A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Pri

The purpose of this study is to find out if giving heated chemotherapy into the belly, known as
heated intraperitoneal chemotherapy (HIPEC), improves the treatment of your type of cancer.
The goal of HIPEC is to expose any cancer left in the belly after surgery to high doses of
chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get
into and kill the cancer cells. The drug used for HIPEC will be cisplatin, a Food and Drug
Administration (FDA) approved drug for use in ovarian, fallopian tube or primary peritoneal
cancer, although it has not specifically been approved for use for HIPEC.

For more information, visit: https://clinicaltrials.gov/study/NCT05659381

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

1. Patients must have a pathologic diagnosis of high grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage III or IV documented on CT scan/MRI, must be recommended to undergo neoadjuvant chemotherapy (3-4 cycles allowed) and are considered candidates for interval cytoreductive surgery (iCRS) as determined by the enrolling investigator.
2. Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases).
3. Patient must have no gross residual disease or no disease >1.0 cm in largest diameter following iCRS and prior to randomization.
4. Patients must have Myriad my Choice HRD test results available prior to registration.
5. Patient must have adequate bone marrow and organ function:
   • Bone marrow function:
     • Hemoglobin ≥ 8.5 g/dL. Absolute neutrophil count (ANC) ≥ 1,000/mm3. Platelets ≥ 100,000/mm3.
   • Renal function:
     • Creatinine ≤ 1.3mg/dl Calculated creatinine clearance (≥ 30 mL/min/1.73 m2) per National Kidney Foundation guidelines and NHANES III
   • Hepatic function:
     • Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN.
   • Neurologic function:
     • Peripheral neuropathy ≤ CTC AE grade 2.
   • Blood coagulation parameters:
     • PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT <1.2 times the ULN.
6. Patients must have a GOG performance status of 0 or 1.
7. Patient must be age > 18.
8. Patients must have a life expectancy > 3 months.

1. Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors.
2. Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy.
3. Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan/MRI required within 28 days of iCRS).
4. Patients not eligible to iCRS based on medical co-morbidites as per enrolling investigator.
5. Patients with stage IV disease without complete response of extra-abdominal disease on preoperative imaging (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) who are not deemed resectable with iCRS.
6. Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.
7. Patients who are pregnant or lactating.
8. Patients with a hypersensitivity or allergy to paclitaxel, docetaxel, carboplatin, cisplatin, or niraparib.