PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAzienda Ospedaliera Universitaria Integrata Verona
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Extraperitoneal metastases
PCI >6
Gastro-esophageal junction tumor of esophageal relevance (Siewert I-II)
Previous allergic reactions to cisplatin or doxorubicin
Trial design
Design model
Parallel
Treatments tested in this trial
FOLFOX and PIPAC
Combination productA minilaparotomy is performed in the midline. A 5 mm balloon trocar is inserted under "finger protection" in the right side and the fascia of the minilaparotomy is closed. The abdomen is insufflated with CO2 and a second 10-12mm trocar is introduced under videoscope control in upper left side. Ascites volume is documented and removed sending a sample for cytological examination, an accurate exploratory laparoscopy is performed, possibly placing an additional 5 or 10-12 mmHg trocar, the Peritoneal Cancer Index is calculated. Multiple biopsies are performed in different abdominal quadrants. A nebulizer CAPNOPEN© is inserted into the upper left side trocar and fixed with a 45° angle. The drugs (Cisplatin 10.5 mg/m2 body surface in 150 mL; Doxorubicin 2.1 mg/m2 body surface in 50 mL) are then injected through remote control with a flow rate of 0.7 mL/sec with a pressure of 200 psi. After an aerosol exposure phase of 30min, the aerosol is evacuated via a closed waste system.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Arm A (FOLFOX)Active comparator 1 intervention
Group B: Arm B (FOLFOX and PIPAC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Secondary Resectability Rate (percent)
The rate of patients of the two arms that get radical intent surgery (cytoreductive surgery and HIPEC)
Time frame
Three and a half yearsSecondary outcomes
1
OS
Overall Survival
Time frame
Three and a half years2
PFS
Progression-Free Survival
Time frame
Three and a half years3
DRS
Disease-related survival
Time frame
Three and a half years4
PRGS
Peritoneal Regression Grade Score: Grade 1 complete response; Grade 2 major response; Grade 3 minor response; Grade 4 no response.
Time frame
Three and a half yearsSponsors and contacts
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Source ClinicalTrials.gov