Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in multimodal therapy for patients with oligometastatic peritoneal gastric cancer: a randomized multicenter phase III trial. PIPAC_VEROne

Phase 1

Active, not recruiting

Conditions: Gastric adenocarcinoma with peritoneal metastases
MedDRA version: 21.1Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2021-000830-33-IT

Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 98

Inclusion Criteria

• Age between 18-75 years
• Primary gastric adenocarcinoma of first diagnosis not previously treated
• Laparoscopic finding of positive peritoneal cytology and / or peritoneal localizations of disease (PCI = 6), confirmed by histological examination.
• Signature of informed consent
• ECOG PS scale 0-1
Patients of childbearing potential will be included in the study and monitored by serum pregnancy tests before each chemotherapy cycle and each PIPAC and at the end of treatment.
Oral contraceptives will not be used due to the already high thrombotic risk related to the disease, but all other contraceptives will be used according to CTFG indications on contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

• Presence of extraperitoneal metastases;
• PCI> 6;
• Localization of the primary site of disease in the gastric esophagus junction of esophageal relevance (Siewert I-II);
• Previous allergic reactions to cisplatin or doxorubicin;
• Haemorrhagic or occlusive manifestation of disease that candidates the patient for palliative surgery;
• ASA IV;
• Refusal of the patient to sign the consent;
• positive on diagnostic biopsies for EBV, MSI and HER2;
• pregnancy and breastfeeding;
• hypersensitivity to the active substances or to any of the excipients
• liver failure (AST) / ALT> 3 times normal values, ALT> 3 times normal values, Bilirubin> 1.5 normal values)
• Creatininemia> 1.25 mg / dL
• Ischemic / haemorrhagic stroke within the past 6 months
• Acute myocardial infarction within the past 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 30ml / min