Clinical Trial

PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer

Study acronym: PIPAC_VEROne
Recruiting Phase 3
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Record status
This record was last updated February 21, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-03-28; most recent amendment 2025-02-19.
Status change: Not Yet Recruiting → Recruiting 2022-07-19
Trial Details
NCT Number NCT05303714
Lead Sponsor Azienda Ospedaliera Universitaria Integrata Verona
Conditions Oligometastatic Gastric Adenocarcinoma
Enrollment 98 participants
Start Date 2022-03-31
Primary Completion 2025-09-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-21