NCT05406674

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• FIGO Stage III Ovarian Cancer
• Peritoneal Cancer
• Fallopian Tube Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin 100 mg/m2	Cisplatin 100 mg/m2 milligram(s)/square meter
DRUG	Cisplatin 40 mg/l	Cisplatin 40 mg/I milligram(s)/litre

Timeline

• Start date: 2022-06-15
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2022-06-06
• Last updated: 2025-07-20

Locations

2 sites across 1 country: Netherlands