Clinical trial NCT04956068: PIPAC for Peritoneal Metastases
Official title: Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Peritoneal Metastases
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 UGI ECOG \< 3
* In UGI PM patients, progression while on bidirectional chemotherapy

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of patients with major toxicities of at least CTCAE Grade 3 and above
timeFrame: Up to 4 weeks after each PIPAC procedure
measure: Number of patients with minor toxicities of CTCAE Grade 1 and 2
timeFrame: Up to 4 weeks after each PIPAC procedure
measure: Length of hospitalisation stay for each PIPAC procedure
timeFrame: Through study completion, an average of half a year
Secondary outcomes:
measure: Intra-operative Peritoneal Carcinomatosis Index (PCI) score
timeFrame: During each PIPAC procedure
measure: Ascites volume
timeFrame: During each PIPAC procedure
measure: Peritoneal Regression Grading Score (PRGS) from PM biopsy
timeFrame: At each PIPAC procedure
measure: Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
timeFrame: 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)
measure: Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire
timeFrame: 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)
measure: Progression free survival
timeFrame: From the start of the first PIPAC procedure, up to 5 years
measure: Overall survival
timeFrame: From the start of the first PIPAC procedure, up to 5 years
measure: Percentage of patients that convert to curative surgery
timeFrame: From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Claramae Chia, MBBS
role: PRINCIPAL_INVESTIGATOR
References: