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PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer

NCT05303714 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-02-21

No results posted yet for this study

Summary

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

  • Oligometastatic Gastric Adenocarcinoma

Interventions

COMBINATION_PRODUCT

FOLFOX and PIPAC

A minilaparotomy is performed in the midline. A 5 mm balloon trocar is inserted under "finger protection" in the right side and the fascia of the minilaparotomy is closed. The abdomen is insufflated with CO2 and a second 10-12mm trocar is introduced under videoscope control in upper left side. Ascites volume is documented and removed sending a sample for cytological examination, an accurate exploratory laparoscopy is performed, possibly placing an additional 5 or 10-12 mmHg trocar, the Peritoneal Cancer Index is calculated. Multiple biopsies are performed in different abdominal quadrants. A nebulizer CAPNOPEN© is inserted into the upper left side trocar and fixed with a 45° angle. The drugs (Cisplatin 10.5 mg/m2 body surface in 150 mL; Doxorubicin 2.1 mg/m2 body surface in 50 mL) are then injected through remote control with a flow rate of 0.7 mL/sec with a pressure of 200 psi. After an aerosol exposure phase of 30min, the aerosol is evacuated via a closed waste system.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Francesco Casella · General and Upper GI Surgery, University of Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2025-09-30
Completion
2028-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303714 on ClinicalTrials.gov