Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 15, 2021

Study Completion Date

June 16, 2022

Conditions
Ovarian Epithelial Cancer RecurrentPlatinum-resistant
Interventions
DEVICE

Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin

After insufflation of a 12 mmHg of capnoperitoneum at 37 °C, two balloon trocars will be placed. Parietal biopsies will be taken and ascites (\< 500cc) will be removed. A nebulizer will be connected to a high-pressure injector and will be inserted into the abdomen through a trocar. A pressurized aerosol containing cisplatin at a dose of 10.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 2.1 mg/m2 body surface in a 50 ml NaCl 0.9% solution will be applied via a nebulizer immediately. Then, the system will be kept in steady-state for 30 min (i.e.: application time).

Trial Locations (1)

00168

Catholic University of Sacred Heart, Rome

All Listed Sponsors
lead

Catholic University of the Sacred Heart

OTHER

NCT02735928 - Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor | Biotech Hunter | Biotech Hunter