PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2028

Conditions
Oligometastatic Gastric Adenocarcinoma
Interventions
COMBINATION_PRODUCT

FOLFOX and PIPAC

"A 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."

Trial Locations (1)

37126

RECRUITING

AOUI Verona, Verona

All Listed Sponsors
lead

Azienda Ospedaliera Universitaria Integrata Verona

OTHER