PIPAC for Peritoneal Metastases
- Trial number:
- NCT04956068
- Trial phase:
- 1
- Study type:
- Chemotherapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
For Unesectable PM Group:
Age ≥ 21 years oldECOG < 3 Fit for systemic chemotherapy treatment Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L Adequate renal function (e-GFR > 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin) Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3 upper limit of normal) No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin No contraindications to general anaesthesia and diagnostic laproscopy procedure Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin) Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries Peritoneal-dominant metastatic disease
For the Extensive PM Group:
All the above mentioned criteria as for the unresectable group, with the addition of the following:
Not suitable for curative cytoreductive surgery (CRS) & hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6 in UGI ECOG < 3In UGI PM patients, progression while on bidirectional chemotherapy