CClinicalTrials.gg
Sign In
Active, not recruitingNCT05406674CisConUpdated Jul 20, 2025

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

A Phase 2 interventional study of Cisplatin 100 mg/m2 and Cisplatin 40 mg/l in FIGO Stage III Ovarian Cancer, Peritoneal Cancer and Fallopian Tube Carcinoma, sponsored by The Netherlands Cancer Institute. Active, not recruiting at 2 sites in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by The Netherlands Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • FIGO Stage III Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Carcinoma
03

In context

Fallopian Tube Neoplasms

720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.

This study's planned enrollment of 40 is below the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.

Browse Fallopian Tube Neoplasms studies →

Lead sponsor

The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. history of previous malignancy treated with chemotherapy
  2. opting for fertility-sparing surgery
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugCisplatin 100 mg/m2

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

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

  • DrugCisplatin 40 mg/l

    Cisplatin 40 mg/I milligram(s)/litre

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

06

What researchers measure

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)

    Grade 3-5 will be reported

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

  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

07

Study locations

2 sites
  • Antoni van Leeuwenhoek (NKI-AVL)
    Amsterdam, 1066 CX, Netherlands
  • UMCU
    Utrecht, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05406674
Lead sponsor
The Netherlands Cancer Institute
Responsible party
Sponsor
First posted
Jun 6, 2022
Start date
Jun 15, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 20, 2025

Study contacts

W. van Driel, MD PhD
principal investigator · NKI-AvL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fallopian Tube Neoplasms→

Other studies from this sponsor

The Netherlands Cancer Institute

Start the discussion