PIPAC for Peritoneal Metastases

Trial number:
NCT04956068
Trial phase:
1
Study type:
Chemotherapy
Overall status:
Recruiting

Study start date

May, 2021

Scientific title

Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases

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.

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

- 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)

Study design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Peritoneal Metastases

Other study ID numbers

PIPAC

Choose trial site (1)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
11 Hospital Cres, Singapore 169610