NCT05406674Active, not recruitingPhase 2
Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 31 May 2022
- Start date
- 15 Jun 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Ovarian cancer
- NCT number
- NCT05406674
- EU CT number
- 2024-514711-99-00
- EudraCT number
- 2021-006809-29
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 15 Jun 2022 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- opting for fertility-sparing surgery
Other illness
- history of previous malignancy treated with chemotherapy
Who the study is looking for
- signed and written informed consent
- age ≥ 18 years
- patients eligible for interval cytoreductive surgery
- histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer
- when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8
- neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel
- following 2 cycles of chemotherapy no progression should occur
- treated with optimal or complete interval cytoreductive surgery
- fit for major surgery, WHO performance status 0-2
- adequate bone marrow function (hemoglobin level \>5.5 mmol/L; leukocytes \>3 x 109/L; platelets \>100 x 109 /L)
- adequate hepatic function (ALT, AST and bilirubin \<2.5 times upper limit of normal)
- adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)
- able to understand the patient information
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.