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

Peritoneal Cancer Clinical Trial

— CisCon  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406674
• Other study ID #: N21CCI
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: The Netherlands Cancer Institute
• Contact: W. van Driel, MD PhD
• Phone: +31 20 512 9111
• Email: w.v.driel[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Carcinoma
• FIGO Stage III Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Drug:
• Cisplatin 100 mg/m2
Cisplatin 100 mg/m2 milligram(s)/square meter
• Cisplatin 40 mg/l
Cisplatin 40 mg/I milligram(s)/litre

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek (NKI-AVL)	Amsterdam
Netherlands	UMCU	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratumoral platinum (Pt) concentration at the end of perfusion after 90 minutes (in ng/mg wet tissue)		End of perfusion after 90 minutes
Secondary	Toxicity evaluation (CTCAE 5.0)	Grade 3-5 will be reported	The occurrence of adverse events will be monitored until 6 weeks after surgery
Secondary	Platinum (Pt) concentration in normal tissue (in ng/mg wet tissue)		End of perfusion
Secondary	Platinum (Pt) concentration in tumor tissue after 30 minutes and 60 minutes of perfusion (in ng/mg wet tissue)		After 30 minutes and 60 minutes of perfusion
Secondary	Concentration versus time curve and area-under-the-curve (AUC) of intra-peritoneal Platinum (Pt) during perfusion		During perfusion
Secondary	Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion		During perfusion
Secondary	Time to Maximum Concentration (Tmax) Platinum (Pt) in perfusate during perfusion		During perfusion
Secondary	Terminal elimination half-life (t1/2) Platinum (Pt) in perfusate during perfusion		During perfusion
Secondary	Clearance from perfusate at the end of perfusion		End of perfusion
Secondary	Overall Survival (OS)		Will be evaluated after 3 and 5 years after the last patient last visit