Intraoperative Intraperitoneal Chemoperfusion to Treat Peritoneal Minimal Residual Disease in Stage III Ovarian Cancer

Inclusion Criteria

• •Tumor type:
• •\* Biopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma
• •Primary or recurrent disease
• •Extent of disease:
• •* Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III, Appendix (47))
• •* Stage IV with unilateral pleural fluid allowed
• •* 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
• •Adequate performance status (Karnofsky index \> 70%)
• •Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
• •Expected life expectancy more than 6 months
• •Laboratory data:
• •* Serum creatinine ≤ 1.5 mg/dl or a calculated Glomerular Filtration Rate (GFR) (CKD-EPI) ≥ 60 mL/min/1.73 m2
• •* Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
• •* Platelet count \> 100.000/µl
• •* Hemoglobin \> 9g/dl
• •* Neutrophil granulocytes \> 1.500/ml
• •* 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