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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04956068
Other study ID # PIPAC
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 20, 2021
Est. completion date November 2024

Study information

Verified date May 2024
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
Health authority
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 2024
Est. primary completion date November 2024
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)

Study Design


Related Conditions & MeSH terms


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
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