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

NCT05406674 | Active Not Recruiting Phase 2

• 1 other identifier: N21CCI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 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.

Conditions

FIGO Stage III Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Carcinoma

Outcome Measures

Primary Outcomes (1)

• Intratumoral platinum (Pt) concentration at the end of perfusion after 90 minutes (in ng/mg wet tissue)

  End of perfusion after 90 minutes

Secondary Outcomes (9)

• Toxicity evaluation (CTCAE 5.0)

  The occurrence of adverse events will be monitored until 6 weeks after surgery

• Platinum (Pt) concentration in normal tissue (in ng/mg wet tissue)

  End of perfusion

• 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

• Concentration versus time curve and area-under-the-curve (AUC) of intra-peritoneal Platinum (Pt) during perfusion

  During perfusion

• Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion

  During perfusion

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Patients in Arm A are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cispaltin-based HIPEC with a dosage of 100 mg/m2

Drug: Cisplatin 100 mg/m2

Arm B

EXPERIMENTAL

Patients in Arm B are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cisplatin- based HIPEC with a dosage of 40 mg/L perfusate.

Drug: Cisplatin 40 mg/l

Interventions

Cisplatin 100 mg/m2 DRUG

Cisplatin 100 mg/m2 milligram(s)/square meter

Also known as: LO1XA, NDC 16729-288, SUB07483MIG, PL 20075/0123

Arm A

Cisplatin 40 mg/l DRUG

Cisplatin 40 mg/I milligram(s)/litre

Also known as: LO1XA, NDC 16729-288, SUB07483MIG, PL 20075/0123

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• history of previous malignancy treated with chemotherapy
• opting for fertility-sparing surgery

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (2)

Antoni van Leeuwenhoek (NKI-AVL)

Amsterdam, 1066 CX, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• W. van Driel, MD PhD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients in Arm A are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cispaltin-based HIPEC with a dosage of 100 mg/m2. Patients in Arm B are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cisplatin- based HIPEC with a dosage of 40 mg/L perfusate.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: June 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

NL (2)