Comparing two dosing methods of Cisplatin for chemotherapy in advanced ovarian cancer
Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
This study is testing two different ways to give Cisplatin chemotherapy to women with advanced ovarian cancer to see which method works better and is safer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT05406674 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two different dosing strategies for hyperthermic intraperitoneal chemotherapy (HIPEC) using Cisplatin in women with advanced ovarian cancer. The study will evaluate the pharmacokinetics and safety of body surface area-based versus concentration-based dosing methods following cytoreductive surgery. Participants will receive either 100 mg/m2 or 40 mg/l of Cisplatin, and the outcomes will help determine the most effective approach for chemotherapy delivery in this patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed FIGO stage III high-grade serous ovarian, fallopian tube, or extra-ovarian cancer who are eligible for interval cytoreductive surgery.
Not a fit: Patients with lower performance status or those who have not responded adequately to prior chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize chemotherapy dosing, potentially improving treatment outcomes for women with advanced ovarian cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in ovarian cancer, but this specific comparison of dosing methods is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 1 other locations
- Antoni van Leeuwenhoek (NKI-AVL) — Amsterdam, Netherlands (Recruiting)
- Umcu — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: W. van Driel, MD PhD — NKI-AvL
- Study coordinator: W. van Driel, MD PhD
- Email: w.v.driel@nki.nl
- Phone: +31 20 512 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.