PIPAC for Peritoneal Metastases

Peritoneal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956068
• Other study ID #: PIPAC
• Status: Recruiting
• Phase: Phase 1
• Start date: May 20, 2021
• Est. completion date: November 2023

Study information

• Verified date: December 2021
• Source: National Cancer Centre, Singapore
• Contact: Claramae Chia, MBBS
• Phone: +65 6436 8000
• Email: claramae.chia.s.l[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Peritoneal Metastases

Intervention

Combination Product:
• PIPAC
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

Country	Name	City	State
Singapore	National Cancer Center Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Length of hospitalisation stay for each PIPAC procedure		Through study completion, an average of half a year
Secondary	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
Secondary	Ascites volume	To examine the clinical response of PM after PIPAC	During each PIPAC procedure
Secondary	Peritoneal Regression Grading Score (PRGS) from PM biopsy	To examine the clinical response of PM after PIPAC	At each PIPAC procedure
Secondary	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)
Secondary	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)
Secondary	Progression free survival		From the start of the first PIPAC procedure, up to 5 years
Secondary	Overall survival		From the start of the first PIPAC procedure, up to 5 years
Secondary	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