drugset / Trial / NCT05406674

Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer

NCT05406674 ↗

Phase 2 Active not recruiting 40 enrolled The Netherlands Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-15
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 0.04 mg/ml Other
Comparator Cisplatin Other / unclassified 100 mg/m2 Other