Status:
ACTIVE_NOT_RECRUITING
Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
FIGO Stage III Ovarian Cancer
Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 evid...
Eligibility Criteria
Inclusion
- 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
Exclusion
- history of previous malignancy treated with chemotherapy
- opting for fertility-sparing surgery
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05406674
Start Date
June 15 2022
End Date
December 1 2027
Last Update
July 20 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, Netherlands, 1066 CX
2
UMCU
Utrecht, Netherlands