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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56202

Enrollment

Registered

2022-05-02

Start date

2022-09-01

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

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, with a maximum dose of 220 mg Patien

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. signed and written informed consent 2. age >= 18 years 3. 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; 4. peritoneal disease present at the start of cytoreductive surgery 5. treated with optimal or complete interval cytoreductive surgery 6. fit for major surgery, WHO performance status 0-2 7. adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L) 8. adequate hepatic function (ALT, AST and bilirubin = 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI) 10. able to understand the patient information

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint is platinum concentration in the tumor nodule at the end of the HIPEC procedure.	—

Secondary

Measure	Time frame
Secondary endpoints are pharmacokinetic parameters (AUCip, Cmax, Tmax, t1/2 in perfusate, clearance from abdominal cavity), platinum concentration in normal tissue, platinum concentration in tumor tissue after 30 min and 60 min of perfusion, and post-operative complications (CTCAE 5.0), Recurrence-free survival (RFS) and Overall survival (OS)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)