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

October 4, 2023 updated by: The Netherlands Cancer Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: W. van Driel, MD PhD
  • Phone Number: +31 20 512 9111
  • Email: w.v.driel@nki.nl

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antoni van Leeuwenhoek (NKI-AVL)
        • Contact:
      • Utrecht, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
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
Cisplatin 100 mg/m2 milligram(s)/square meter
Other Names:
  • LO1XA
  • NDC 16729-288
  • SUB07483MIG
  • PL 20075/0123
Experimental: Arm B
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
Cisplatin 40 mg/I milligram(s)/litre
Other Names:
  • LO1XA
  • NDC 16729-288
  • SUB07483MIG
  • PL 20075/0123

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of perfusion after 90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The occurrence of adverse events will be monitored until 6 weeks after surgery
Platinum (Pt) concentration in normal tissue (in ng/mg wet tissue)
Time Frame: End of perfusion
End of perfusion
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
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
Time Frame: During perfusion
During perfusion
Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion
Time Frame: During perfusion
During perfusion
Time to Maximum Concentration (Tmax) Platinum (Pt) in perfusate during perfusion
Time Frame: During perfusion
During perfusion
Terminal elimination half-life (t1/2) Platinum (Pt) in perfusate during perfusion
Time Frame: During perfusion
During perfusion
Clearance from perfusate at the end of perfusion
Time Frame: End of perfusion
End of perfusion
Overall Survival (OS)
Time Frame: Will be evaluated after 3 and 5 years after the last patient last visit
Will be evaluated after 3 and 5 years after the last patient last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: W. van Driel, MD PhD, NKI-AVL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N21CCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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