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

Netherlands Cancer Institute (NKI)

Status and phase: Enrolling; Phase 2

Conditions: FIGO Stage III Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Carcinoma

Treatments: Drug: Cisplatin 100 mg/m2; Drug: Cisplatin 40 mg/l

Study type: Interventional

Funder types: Other

Identifiers

NCT05406674

N21CCI

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm A

Active Comparator group

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

Treatment:

Drug: Cisplatin 100 mg/m2

Arm B

Experimental group

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.

Treatment:

Drug: Cisplatin 40 mg/l