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Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
Sponsor: The Netherlands Cancer Institute
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-06-15
Completion Date
2027-12
Last Updated
2025-07-20
Healthy Volunteers
No
Interventions
Cisplatin 100 mg/m2
Cisplatin 100 mg/m2 milligram(s)/square meter
Cisplatin 40 mg/l
Cisplatin 40 mg/I milligram(s)/litre
Locations (2)
Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, Netherlands
UMCU
Utrecht, Netherlands