Trial intelligence / Profile preview

Cisplatin Dosing Strategies for HIPEC in Ovarian Cancer

NCT05406674Phase 2

Key facts

Status: Active, not recruiting
Start: Jun 2022
Primary completion: Dec 2026
Countries: 1
Sponsor: Netherlands Cancer Institute
Modality: Small Molecules

Drugs: cisplatin
Conditions: ovarian cancerfallopian tube cancer (PFTC)primary peritoneal cancer (PPC)

Overview

Phase 2, randomised, open-label trial of cisplatin in ovarian cancer, fallopian tube cancer (PFTC) and primary peritoneal cancer (PPC) (2 arms), sponsored by Netherlands Cancer Institute. Primary endpoint: Intratumoral platinum concentration at the end of perfusion. Started Jun 2022; status: active, not recruiting.

Design

2 arms

Study design: RandomizedOpen-label

BSA-based Dosing
Cisplatin 100 mg/m2
Concentration-based Dosing
Cisplatin 40 mg/L

Who it enrols

Patients with FIGO stage III high grade serous ovarian, fallopian tube, or extra-ovarian cancer eligible for interval cytoreductive surgery after 3 courses of carboplatin/paclitaxel without progression.

Endpoints

Primary

Intratumoral platinum concentration at the end of perfusion90 min

Secondary

Toxicity evaluation (CTCAE 5.0)6 weeks
Platinum concentration in normal tissueEnd of perfusion
Platinum concentration in tumor tissue after 30 and 60 minutes60 min
Area-under-the-curve of intra-peritoneal Platinum during perfusionDuring perfusion
Maximum Concentration of Platinum in perfusateDuring perfusion
Overall Survival5 years

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