NCT05303714RecruitingPhase 3
PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal 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
Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 oligometastatic gastric cancer should be investigated in clinical trials. PIPAC VER-One is a prospective, randomized, multicenter phase III clinical trial with two arms that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with Gastric Cancer and synchronous positive peritoneal cytology and/or limited peritoneal metastases (PCI ≤ 6). Patients will be randomized into two arms: arm A (control) treated with the current standard that is systemic chemotherapy only and Arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy (1 PIPAC every 2 systemic chemotherapy cycles). Primary endpoint is the Secondary Resectability Rate. Secondary endpoints are: Overall Survival, Progression Free Survival, Disease Free Survival, histological response assessed both on primary tumor and peritoneal lesions, Quality of Life, complication rate (CTCAE v5), incremental cost-effectiveness ratios (ICER).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 15 Feb 2022
- Start date
- 31 Mar 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05303714
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 98
- From 31 Mar 2022 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allergic reactions to cisplatin or doxorubicin
- Hemorrhagic or occlusive manifestation of the primary tumor with palliative surgery needed
- Contraindication to any drug contained in the chemotherapy regimen
Other illness
- Ischemic/hemorrhagic stroke in the last 6 months
- Acute myocardial infarction in the last 6 months
- Moderate/severe heart failure (NYHA III-IV)
- Active hepatitis B or C
- HIV infection
Lab values
- Hepatic impairment (AST/ALT\> 3 times normal values, ALT\>3 times normal values, Bilirubin\>1.5 normal values)
- Creatinine clearance less than 30 ml/min
Other
- Extraperitoneal metastases
- PCI \>6
- Gastro-esophageal junction tumor of esophageal relevance (Siewert I-II)
- ASA IV
- Positivity for EBV, MSI and HER2 on diagnostic biopsies
- Pregnancy and breastfeeding
- Leukopenia\< 2,000/μl
- Thrombocytopenia \< 100,000/μl
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOUI Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.