Cytoreductive surgery (CRS) with the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) is used in current clinical practice in selected patients with advanced ovarian cancer. Clinical evidence for the benefit of HIPEC in ovarian cancer comes from the pivotal phase 3 OVHIPEC trial. Worldwide, two established strategies exist for dosing of HIPEC protocols, which follow either a body surface area (BSA)-based or a concentration-based approach. Since both strategies result in different exposure to intra-peritoneal chemotherapy, we aim to compare the pharmacokinetics and safety of both strategies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Cisplatin 100 mg/m2 milligram(s)/square meter
Cisplatin 40 mg/I milligram(s)/litre
Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, Netherlands
UMCU
Utrecht, Netherlands
Intratumoral platinum (Pt) concentration at the end of perfusion after 90 minutes (in ng/mg wet tissue)
Time frame: End of perfusion after 90 minutes
Toxicity evaluation (CTCAE 5.0)
Grade 3-5 will be reported
Time frame: The occurrence of adverse events will be monitored until 6 weeks after surgery
Platinum (Pt) concentration in normal tissue (in ng/mg wet tissue)
Time frame: End of perfusion
Platinum (Pt) concentration in tumor tissue after 30 minutes and 60 minutes of perfusion (in ng/mg wet tissue)
Time frame: After 30 minutes and 60 minutes of perfusion
Concentration versus time curve and area-under-the-curve (AUC) of intra-peritoneal Platinum (Pt) during perfusion
Time frame: During perfusion
Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion
Time frame: During perfusion
Time to Maximum Concentration (Tmax) Platinum (Pt) in perfusate during perfusion
Time frame: During perfusion
Terminal elimination half-life (t1/2) Platinum (Pt) in perfusate during perfusion
Time frame: During perfusion
Clearance from perfusate at the end of perfusion
Time frame: End of perfusion
Overall Survival (OS)
Time frame: Will be evaluated after 3 and 5 years after the last patient last visit
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