Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Peritoneal Carcinosis (PC)
Interventions
PROCEDURE

cytoreductive surgery and HIPEC

"The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C).~The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC.~Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU)."

Trial Locations (1)

69495

Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud, Pierre-Bénite

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT01226550 - Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan | Biotech Hunter | Biotech Hunter