Status:
RECRUITING
PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Oligometastatic Gastric Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 p...
Detailed Description
This is a prospective, open label, randomized multicenter phase III clinical study that aims to evaluate the effects of PIPAC combined with systemic chemotherapy vs. intravenous systemic chemotherapy ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05303714
Start Date
March 31 2022
End Date
September 30 2028
Last Update
February 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AOUI Verona
Verona, Italy, 37126