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ACTIVE NOT RECRUITING
NCT05406674
PHASE2

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

View on ClinicalTrials.gov

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

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

Locations (2)

Antoni van Leeuwenhoek (NKI-AVL)

Amsterdam, Netherlands

UMCU

Utrecht, Netherlands