PIPAC for Peritoneal Metastases

  • STATUS
    Recruiting
  • End date
    Nov 29, 2023
  • participants needed
    25
  • sponsor
    National Cancer Centre, Singapore
Updated on 29 December 2021

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.

Details
Condition Peritoneal Metastases
Treatment PIPAC
Clinical Study IdentifierNCT04956068
SponsorNational Cancer Centre, Singapore
Last Modified on29 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
In UGI PM patients, progression while on bidirectional chemotherapy
UGI ECOG < 3

Exclusion Criteria

Any medical or psychiatric condition(s) which would preclude informed consent
Patient is medically unfit for surgery due to concurrent medical comorbidities
Patient is pregnant or nursing
including but not limited to intestinal obstruction, multiple sites of metastases
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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