stage III ovarian cancer
Conditions
Interventions
Trade Name: Cisplatin Hospira
Product Name: Cisplatine Hospira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cisplatine Hospira
Other descriptive name: CISPLATIN
Concentration unit:
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Tumor type o Biopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma ? Primary or recurrent disease ? Extent of disease o Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III) o Stage IV with unilateral pleural fluid allowed o Complete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both ? Second-line patients; platinum sensitive ? Age over 18 years ? No major cardiac or respiratory disease ? Absent or limited ( 70%) ? Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent ? Expected life expectancy more than 6 months ? Laboratory data o Serum creatinine ? 1.5 mg/dl or a calculated GFR (CKD-EPI) = 60 mL/min/1.73 m2 o Serum total bilirubin ? 1.5 mg/dl, except for known Gilbert’s disease o Platelet count > 100.000/µl o Hemoglobin > 9g/dl o Neutrophil granulocytes > 1.500/ml o International Normalized Ratio (INR) ? 2 ? Absence of alcohol and/or drug abuse ? No other concurrent malignant disease ? No inclusion in other clinical trials interfering with the study protocol ? No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy ? Absence of any severe organ insufficiency ? No pregnancy or breast feeding ? Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: ? Severe or uncontrolled cardiac insufficiency, including recent ( 12 months after completion of Pt containing therapy) or refractory disease ? Active bacterial, viral or fungal infection ? Active gastro-duodenal ulcer ? Parenchymal liver disease (any stage cirrhosis) ? Uncontrolled diabetes mellitus ? Severe obstructive or restrictive respiratory insufficiency ? Psychiatric pathology capable of affecting comprehension and judgment faculty ? Tumor in the presence of obstruction ? Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis ? Peritoneal cancer index (sPCI) = 25
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of cytoreductive surgery (CRS) and efficacy of cisplatin-based intraoperative intraperitoneal chemoperfusion (IPEC) in patients with primary or recurrent serous epithelial ovarian cancer (OC), in order to treat peritoneal minimal residual disease (pMRD).;Secondary Objective: To study the pharmacodynamics of IP drug delivery and the value of hyperthermic administration.;Primary end point(s): Tissue penetration distance of cisplatin in peritoneal tumor tissue nodules ;Timepoint(s) of evaluation of this end point: end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Postoperative morbidity and mortality o Quality of Life o Pharmacokinetics of cisplatin in peritoneal perfusate and plasma samples o Pharmacodynamics: Pt DNA adduct formation o Overall survival, disease free survival, peritoneal recurrence free survival o Effects of (H)IPEC on peritoneal cytology o Translational research: analyzing gene expression of selected biomarkers for Pt sensitivity, stromal density and composition of tumor slices. ;Timepoint(s) of evaluation of this end point: o Postoperative morbidity and mortality: 30 days after debulking o Quality of Life: preoperatively, after 6 weeks and after 3, 6, 12, 18 and 24 months. | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed