PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer
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) resul
| Condition(s) | Oligometastatic Gastric Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 oligometa |
| Who can participate | 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/hemorrha |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
| Locations | Verona, Italy |
| Start date | 2022-03-31 |
| NCT ID | NCT05303714 |
| Official listing | https://clinicaltrials.gov/study/NCT05303714 |