PIPAC for Peritoneal Metastases
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
National Cancer Centre, Singapore
25 participants
May 20, 2021
INTERVENTIONAL
Conditions
Summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.
Eligibility
Inclusion Criteria16
- For Unesectable PM Group:
- Age ≥ 21 years old
- ECOG < 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 < 3
- In UGI PM patients, progression while on bidirectional chemotherapy
Exclusion Criteria4
- Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases
- Any medical or psychiatric condition(s) which would preclude informed consent
- Patient is pregnant or nursing
- GI PM patients with PCI >6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
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Interventions
A novel drug delivery system using the CapnoPen device which allows the aerolisation of chemotherapeutic agents within the peritoneal cavity. PIPAC procedure will be carried out with either oxaliplatin or doxorubicin/ cisplatin.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04956068