Actively Recruiting
PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer
Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2025-02-21
98
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peritoneal Carcinomatosis is the most frequent site of metastases observed in patients with gastric cancer. Current standard treatment for these patients is palliative systemic chemotherapy, but the prognosis is very poor. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) resulted in long-term benefits in selected patients with limited peritoneal involvement. Indeed, among patients with Peritoneal Carcinomatosis, a distinctive subset is oligometastatic disease which is characterized by low metastatic burden. PIPAC is a recent technique of intraperitoneal chemotherapy that can be used in combination with systemic chemotherapy with promising results for patients with PM from gastric cancer. The role of PIPAC in multimodal treatment path for oligometastatic gastric cancer should be investigated in clinical trials. PIPAC VER-One is a prospective, randomized, multicenter phase III clinical trial with two arms that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with Gastric Cancer and synchronous positive peritoneal cytology and/or limited peritoneal metastases (PCI ≤ 6). Patients will be randomized into two arms: arm A (control) treated with the current standard that is systemic chemotherapy only and Arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy (1 PIPAC every 2 systemic chemotherapy cycles). Primary endpoint is the Secondary Resectability Rate. Secondary endpoints are: Overall Survival, Progression Free Survival, Disease Free Survival, histological response assessed both on primary tumor and peritoneal lesions, Quality of Life, complication rate (CTCAE v5), incremental cost-effectiveness ratios (ICER).
CONDITIONS
Official Title
PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary resectable gastric cancer with positive peritoneal cytology and/or low burden peritoneal metastases (PCI 6) confirmed by laparoscopy
- Signed written informed consent
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
You will not qualify if you...
- Presence of metastases outside the peritoneal cavity
- Peritoneal Cancer Index (PCI) greater than 6
- Gastro-esophageal junction tumor classified as Siewert I or II
- Previous allergic reactions to cisplatin or doxorubicin
- Hemorrhagic or obstructive symptoms from the primary tumor requiring palliative surgery
- American Society of Anesthesiologists (ASA) physical status class IV
- Positive for EBV, MSI, or HER2 on diagnostic biopsies
- Pregnancy or breastfeeding
- Contraindications to any chemotherapy drugs used in the study
- Liver impairment with AST/ALT more than 3 times normal or bilirubin greater than 1.5 times normal
- Stroke within the last 6 months
- Heart attack within the last 6 months
- Moderate to severe heart failure (NYHA class III or IV)
- Low white blood cell count (leukopenia < 2,000/µL)
- Low platelet count (thrombocytopenia < 100,000/µL)
- Active hepatitis B or C infection
- HIV infection
- Creatinine clearance less than 30 ml/min
AI-Screening
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Trial Site Locations
Total: 1 location
1
AOUI Verona
Verona, Italy, 37126
Actively Recruiting
Research Team
F
Francesco Casella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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