CISPLATIN for FIGO stage III high-grade serous ovarian cancer | Peritoneal cancer | Fallopian tube carcinoma

Inclusion criteria

• {"criterion_text":"- signed and written informed consent\n- fit for major surgery, WHO performance status 0-2\n- adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)\n- able to understand the patient information\n- age ≥ 18 years\n- 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;\n- peritoneal disease present at the start of cytoreductive surgery\n- treated with optimal or complete interval cytoreductive surgery\n- adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)\n- 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

• {"criterion_text":"- history of previous malignancy treated with chemotherapy\n- opting for fertility-sparing surgery"}

Primary endpoints

• {"endpoint_text":"- intratumoral Pt concentration at the end of perfusion after 90 min (in ng/mg wet tissue)","definition_or_measurement_approach":"Platinum concentration measured in tumor tissue at the end of the 90-minute HIPEC perfusion, reported in ng/mg wet tissue."}

Secondary endpoints

• {"endpoint_text":"- Toxicity evaluation (CTCAE 5.0)","definition_or_measurement_approach":"Toxicity graded using CTCAE v5.0."}
• {"endpoint_text":"- Pt concentration in normal tissue (in ng/mg wet tissue)","definition_or_measurement_approach":"Platinum concentration measured in normal tissue, reported in ng/mg wet tissue."}
• {"endpoint_text":"- Pt concentration in tumor tissue after 30 min and 60 min of perfusion (in ng/mg wet tissue)","definition_or_measurement_approach":"Platinum concentration in tumor tissue measured at 30 and 60 minutes during perfusion, reported in ng/mg wet tissue."}
• {"endpoint_text":"- Concentration versus time curve and AUC of intra-peritoneal Pt during perfusion","definition_or_measurement_approach":"Measurement of intraperitoneal platinum concentration over time during perfusion and calculation of AUC."}
• {"endpoint_text":"- Cmax, tmax, terminal t ½ in perfusate, clearance from perfusate at the end of perfusion","definition_or_measurement_approach":"Pharmacokinetic parameters in perfusate: Cmax, Tmax, terminal half-life, and clearance measured at end of perfusion."}
• {"endpoint_text":"- Recurrence-free survival (RFS) and Overall survival (OS)","definition_or_measurement_approach":"Standard survival endpoints: time to recurrence (RFS) and time to death from any cause (OS)."}

Netherlands

Earliest CTIS Part Ii Submission Date

11-06-2024

Latest Decision Or Authorization Date

13-06-2024

Processing Time Days

2

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands