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

Primary Purpose

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

Status

Recruiting

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Cisplatin 100 mg/m2

Cisplatin 40 mg/l

About this trial

This is an interventional treatment trial for FIGO Stage III Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

signed and written informed consent
age ≥ 18 years
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
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

Sites / Locations

Antoni van Leeuwenhoek (NKI-AVL)Recruiting
UMCURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity evaluation (CTCAE 5.0)

Grade 3-5 will be reported

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

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

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

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

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

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

Clearance from perfusate at the end of perfusion

Overall Survival (OS)

Full Information

NCT ID

NCT05406674

First Posted

May 31, 2022

Last Updated

October 4, 2023

Sponsor

The Netherlands Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT05406674

Brief Title

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

Acronym

CisCon

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm 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

Arm Title

Arm B

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Cisplatin 100 mg/m2

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin 40 mg/l

Other Intervention Name(s)

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

Intervention Description

Cisplatin 40 mg/I milligram(s)/litre

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Toxicity evaluation (CTCAE 5.0)

Description

Grade 3-5 will be reported

Time Frame

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

Title

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

Time Frame

End of perfusion

Title

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

Title

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

Time Frame

During perfusion

Title

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

Time Frame

During perfusion

Title

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

Time Frame

During perfusion

Title

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

Time Frame

During perfusion

Title

Clearance from perfusate at the end of perfusion

Time Frame

End of perfusion

Title

Overall Survival (OS)

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

W. van Driel, MD PhD

Phone

+31 20 512 9111

w.v.driel@nki.nl

First Name & Middle Initial & Last Name or Official Title & Degree

L. Aronson, MD

Phone

+31 20 512 9111

l.aronson@nki.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

W. van Driel, MD PhD

Organizational Affiliation

NKI-AvL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antoni van Leeuwenhoek (NKI-AVL)

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

L. Aronson, MD

Phone

+31 20 512 9111

l.aronson@nki.nl

Facility Name

UMCU

City

Utrecht

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henk Schreuder, MD

Phone

+31 88 75 555 55

H.W.R.Schreuder@umcutrecht.nl

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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