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Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in multimodal therapy for patients with oligometastatic peritoneal gastric cancer: a randomized multicenter phase III trial. PIPAC_VEROne
EU CTIS ID: 2024-515981-14-00
What this study is testing
To evaluate whether the association of PIPAC with chemotherapy compared to chemotherapy alone increases the percentage of patients who undergo surgery with radical intent (CRS and HIPEC). To evaluate whether the association of PIPAC with chemotherapy compared to chemotherapy alone increases the progression-free survival (PFS).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Presence of extraperitoneal metastases
- 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
See the full eligibility 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.
- Presence of extraperitoneal metastases
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.