PIPAC for Peritoneal Metastases

Phase 1RecruitingNCT04956068

National Cancer Centre, Singapore25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peritoneal Metastases

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 4 weeks after each PIPAC procedure

Length of hospitalisation stay for each PIPAC procedure

Time frame: Through study completion, an average of half a year

Secondary Outcomes

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.

Time frame: During each PIPAC procedure

Ascites volume

To examine the clinical response of PM after PIPAC

Time frame: During each PIPAC procedure

Peritoneal Regression Grading Score (PRGS) from PM biopsy

To examine the clinical response of PM after PIPAC

Time frame: 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

Time frame: 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.

Progression free survival

Time frame: From the start of the first PIPAC procedure, up to 5 years

Overall survival

Time frame: 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)

Time frame: From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks