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FIGO Stage III Ovarian CancerPhase 2CisConNCT05406674

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

A Phase 2 study testing Cisplatin 100 mg/m2 and Cisplatin 40 mg/l in people with FIGO Stage III Ovarian Cancer and Peritoneal Cancer, run by The Netherlands Cancer Institute at 2 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cisplatin 100 mg/m2 and Cisplatin 40 mg/l
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesNetherlands
Study dates
15 Jun 2022to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Antoni van Leeuwenhoek (NKI-AVL)

    Amsterdam, 1066 CX

  • UMCU

    Utrecht

Other trials in Netherlands

About this study

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.

Being tested
Cisplatin 100 mg/m2, Cisplatin 40 mg/l
Medical subject headings
Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cisplatin 100 mg/m2Drug

    Also called LO1XA, NDC 16729-288, SUB07483MIG, PL 20075/0123

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

  • Cisplatin 40 mg/lDrug

    Also called LO1XA, NDC 16729-288, SUB07483MIG, PL 20075/0123

    Cisplatin 40 mg/I milligram(s)/litre

Study groups in NCT05406674
Study groupRoleWhat they receive
Arm AActive comparatorPatients 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
Receives: Drug: Cisplatin 100 mg/m2
Arm BExperimentalPatients 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.
Receives: Drug: Cisplatin 40 mg/l

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: End of perfusion after 90 minutes

Secondary outcomes (9)

  1. Toxicity evaluation (CTCAE 5.0)

    Grade 3-5 will be reported

    Measured: 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)

    Measured: End of perfusion

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

    Measured: 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

    Measured: During perfusion

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

    Measured: During perfusion

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

    Measured: During perfusion

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

    Measured: During perfusion

  8. Clearance from perfusate at the end of perfusion

    Measured: End of perfusion

  9. Overall Survival (OS)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2022
  2. Study start15 Jun 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05406674
Sponsor's protocol ID
N21CCI
Acronym
CisCon
Status last verified
Jul 2025
First submitted
31 May 2022
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin 100 mg/m2 and Cisplatin 40 mg/l in people with FIGO Stage III Ovarian Cancer and Peritoneal Cancer, run by The Netherlands Cancer Institute at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05406674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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