Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
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|ClinicalTrials.gov Identifier: NCT01226550|
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : December 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Carcinosis (PC)||Procedure: cytoreductive surgery and HIPEC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
|Experimental: cytoreductive surgery and HIPEC||
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).
- Morbidity rate [ Time Frame: 30 days postoperative ]postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)
- Mortality rate [ Time Frame: 30 days postoperative ]
- Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites. [ Time Frame: per-HIPEC ]Plasma, peritoneal, and urinary values for MMC, irinotecan, SN-38, SN-38G, APC, and NPC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226550
|Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud|
|Pierre Bénite Cedex, France, 69495|