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Awaiting further funding.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unresectable PM group | Experimental | Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy. |
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| Extensive PM group | Experimental | Patients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPAC | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with major toxicities of at least CTCAE Grade 3 and above | To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity. | Up to 4 weeks after each PIPAC procedure |
| Number of patients with minor toxicities of CTCAE Grade 1 and 2 | Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity. | Up to 4 weeks after each PIPAC procedure |
| Length of hospitalisation stay for each PIPAC procedure | Through study completion, an average of half a year |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative Peritoneal Carcinomatosis Index (PCI) score | To examine the clinical response of PM after PIPAC. PCI score from 0 to 39 with a higher number representing a greater amount of disease present in the peritoneum. | During each PIPAC procedure |
| Ascites volume |
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Inclusion Criteria:
For Unesectable PM Group:
For the Extensive PM Group:
All the above mentioned criteria as for the unresectable group, with the addition of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claramae Chia, MBBS | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Singapore | Singapore | 169690 | Singapore |
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To examine the clinical response of PM after PIPAC |
| During each PIPAC procedure |
| Peritoneal Regression Grading Score (PRGS) from PM biopsy | To examine the clinical response of PM after PIPAC | At each PIPAC procedure |
| Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire | Range: 0-108. A high score represents a better health state | At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure) |
| Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire | Range: 0-100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. | At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure) |
| Progression free survival | From the start of the first PIPAC procedure, up to 5 years |
| Overall survival | From the start of the first PIPAC procedure, up to 5 years |
| Percentage of patients that convert to curative surgery | (Only applicable for Extensive PM group) | From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks |