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

Launched by THE NETHERLANDS CANCER INSTITUTE · Jun 3, 2022

Keywords

ClinConnect Summary

This clinical trial is examining two different ways to give a chemotherapy drug called cisplatin during a treatment called hyperthermic intraperitoneal chemotherapy (HIPEC) for women with advanced ovarian cancer. The trial aims to find out which method—dosing based on body surface area or based on the concentration of the drug in the solution—works better and is safer for patients. This is important because the way the drug is given can affect how much of it the body absorbs and how it works to fight cancer.

To participate in this trial, women must be at least 18 years old and have a specific type of advanced ovarian cancer that has not progressed after initial chemotherapy. They should also be fit for major surgery and have good health indicators, such as normal blood counts and liver function. Participants will receive HIPEC treatment as part of their care, and they will be closely monitored for any side effects and how well the treatment works. It's a chance to contribute to important research that could improve treatment options for future patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. signed and written informed consent
• • 2. age ≥ 18 years
• • 3. patients eligible for interval cytoreductive surgery
• • 1. histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer
• • 2. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8
• • 3. neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel
• • 4. following 2 cycles of chemotherapy no progression should occur
• • 4. treated with optimal or complete interval cytoreductive surgery
• • 5. fit for major surgery, WHO performance status 0-2
• • 6. adequate bone marrow function (hemoglobin level \>5.5 mmol/L; leukocytes \>3 x 109/L; platelets \>100 x 109 /L)
• • 7. adequate hepatic function (ALT, AST and bilirubin \<2.5 times upper limit of normal)
• • 8. 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)
• • 9. able to understand the patient information
• Exclusion Criteria:
• • 1. history of previous malignancy treated with chemotherapy
• • 2. opting for fertility-sparing surgery