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NCT Number: NCT05406674

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

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.

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Key information

Conditions

FIGO Stage III Ovarian Cancer Adnexal Diseases Fallopian Tube Carcinoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Cisplatin 100 mg/m2

Drug

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

Other names: LO1XA, NDC 16729-288, SUB07483MIG, PL 20075/0123

Cisplatin 40 mg/l

Drug

Cisplatin 40 mg/I milligram(s)/litre

Other names: LO1XA, NDC 16729-288, SUB07483MIG, PL 20075/0123

Primary outcomes

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

    Time frame: End of perfusion after 90 minutes

Secondary outcomes

  1. Toxicity evaluation (CTCAE 5.0)

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

    Grade 3-5 will be reported

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

    Time frame: End of perfusion

  3. Platinum (Pt) concentration in tumor tissue after 30 minutes and 60 minutes of perfusion (in ng/mg wet tissue)

    Time frame: After 30 minutes and 60 minutes of perfusion

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

    Time frame: During perfusion

  5. Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion

    Time frame: During perfusion

  6. Time to Maximum Concentration (Tmax) Platinum (Pt) in perfusate during perfusion

    Time frame: During perfusion

  7. Terminal elimination half-life (t1/2) Platinum (Pt) in perfusate during perfusion

    Time frame: During perfusion

  8. Clearance from perfusate at the end of perfusion

    Time frame: End of perfusion

  9. Overall Survival (OS)

    Time frame: Will be evaluated after 3 and 5 years after the last patient last visit

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Acronym: CisCon

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 6, 2022
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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