Body surface area-based vs concentration-based dosing of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) in women with advanced ovarian cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 May 2022 → ongoing

Decision date (initial)

2024-06-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514711-99-00

EudraCT number

2021-006809-29

ClinicalTrials.gov

NCT05406674

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Safety, Efficacy

To evaluate BSA-based versus concentration-based OVHIPEC with cisplatin in patients with advanced-stage ovarian cancer.

Secondary objectives 3

1. to compare pharmacokinetic parameters between treatment arms
2. to determine the toxicity for each treatment arm
3. to compare recurrence-free and overall survival between treatment arms.

Conditions and MedDRA coding

FIGO stage III high grade serous ovarian cancer, peritoneal cancer, or fallopian tube carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. signed and written informed consent
2. fit for major surgery, WHO performance status 0-2
3. adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)
4. able to understand the patient information
5. age ≥ 18 years
6. patients eligible for interval cytoreductive surgery with OVHIPEC a. histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer b. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry including keratin 7, keratin 20, p53, PAX8 should be considered (at the discretion of the pathologist) c. neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel d. following 2 cycles of chemotherapy no progression should occur e. resectable, local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions (which is stage IV) are allowed;
7. peritoneal disease present at the start of cytoreductive surgery
8. treated with optimal or complete interval cytoreductive surgery
9. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)
10. 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)

Exclusion criteria 2

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. intratumoral Pt concentration at the end of perfusion after 90 min (in ng/mg wet tissue)

Secondary endpoints 6

1. Toxicity evaluation (CTCAE 5.0)
2. Pt concentration in normal tissue (in ng/mg wet tissue)
3. Pt concentration in tumor tissue after 30 min and 60 min of perfusion (in ng/mg wet tissue)
4. Concentration versus time curve and AUC of intra-peritoneal Pt during perfusion
5. Cmax, tmax, terminal t ½ in perfusate, clearance from perfusate at the end of perfusion
6. Recurrence-free survival (RFS) and Overall survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Willemien van Driel

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Willemien van Driel

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications