The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer

Inclusion Criteria16

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Signed and written informed consent
• At least 18 years of age and able to understand patients' information
• FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.
• FIGO stage IV is allowed in the following situations:
• Resectable stage IV desease, such as local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions
• Stage IV based on cardiophrenic lymph nodes \<1cm
• The diagnosis should be confirmed with either histology or cytology. If the diagnosis of ovarian carcinoma is based on cytology only, immunohistochemistry, including keratin 7, keratin 20, p53, PAX8 should be considered for confirmation of the diagnosis (at the discretion of the pathologist)
• Eligible and planned for interval cytoreductive surgery with HIPEC
• Neo-adjuvant chemotherapy consists of at least 3 courses of carboplatin/paclitaxel
• Patients should have response or stable disease after NACT; no progression should occur
• Operability has been evaluated in a multidisciplinary team (MDT) meeting via CT scan, MRI or diagnostic laparoscopy and an optimal or complete interval CRS is deemed feasible
• Fit for major surgery, WHO performance status 0-2
• Adequate bone marrow function (hemoglobin level \>5.5 mmol/L, leukocytes \>3 x10\^9/L, platelets \> 100 x10\^9/L)
• Adequate hepatic function (ALT, AST, and bilirubin \< 2.5 times the upper limit of normal)
• Adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)