PIPAC combined with chemotherapy for patients with oligometastatic gastric cancer
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer: a Randomized Multicenter Phase III Trial: PIPAC_VEROne
PHASE3 · Azienda Ospedaliera Universitaria Integrata Verona · NCT05303714
This study is testing if a new way of giving chemotherapy directly into the abdomen, along with standard chemotherapy, can help people with a specific type of stomach cancer that has spread a little.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona (other) |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 1 site (Verona) |
| Trial ID | NCT05303714 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of PIPAC, a novel intraperitoneal chemotherapy technique, in combination with systemic chemotherapy for patients with oligometastatic gastric adenocarcinoma. Patients will be randomly assigned to receive either standard intravenous chemotherapy (FOLFOX) or FOLFOX plus PIPAC with cisplatin and doxorubicin. The study aims to evaluate the potential benefits of this multimodal approach in improving outcomes for patients with limited peritoneal metastasis. The trial is designed as a prospective, open-label, randomized multicenter phase III study.
Who should consider this trial
Good fit: Ideal candidates are patients with primary resectable gastric cancer and positive peritoneal cytology or low burden peritoneal metastases confirmed by laparoscopy.
Not a fit: Patients with extraperitoneal metastases or those with a high peritoneal cancer index (PCI > 6) will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with oligometastatic gastric cancer.
How similar studies have performed: While PIPAC is a relatively novel approach, preliminary studies have shown promising results, indicating potential for success in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary resectable gastric cancer with positive peritoneal cytology and/or low burden peritoneal metastases (PCI ≤6) confirmed by laparoscopy * Signature of written informed consent * ECOG PS 0-1 Exclusion Criteria: * Extraperitoneal metastases * PCI \>6 * Gastro-esophageal junction tumor of esophageal relevance (Siewert I-II) * Previous allergic reactions to cisplatin or doxorubicin * Hemorrhagic or occlusive manifestation of the primary tumor with palliative surgery needed * ASA IV * Positivity for EBV, MSI and HER2 on diagnostic biopsies * Pregnancy and breastfeeding * Contraindication to any drug contained in the chemotherapy regimen * Hepatic impairment (AST/ALT\> 3 times normal values, ALT\>3 times normal values, Bilirubin\>1.5 normal values) * Ischemic/hemorrhagic stroke in the last 6 months * Acute myocardial infarction in the last 6 months * Moderate/severe heart failure (NYHA III-IV) * Leukopenia\< 2,000/μl * Thrombocytopenia \< 100,000/μl * Active hepatitis B or C * HIV infection * Creatinine clearance less than 30 ml/min
Where this trial is running
Verona
- AOUI Verona — Verona, Italy (RECRUITING)
Study contacts
- Principal investigator: Francesco Casella — General and Upper GI Surgery, University of Verona
- Study coordinator: Francesco Casella
- Email: francesco.casella@aovr.veneto.it
- Phone: +390458123123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oligometastatic Gastric Adenocarcinoma