Treatment of Primary Peritoneal Carcinosis of Digestive O... | NCT01226550

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
cytoreductive surgery and HIPEC	Experimental		Procedure: cytoreductive surgery and HIPEC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cytoreductive surgery and HIPEC	Procedure	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).

Outcomes Module

Measure	Description	Time Frame
Morbidity rate	postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)	30 days postoperative

Secondary Outcomes

Measure	Description	Time Frame
Mortality rate		30 days postoperative
Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites.	Plasma, peritoneal, and urinary values for MMC, irinotecan, SN-38, SN-38G, APC, and NPC.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a peritoneal carcinosis (PC) either of digestive origin or primary: a colorectal or gastric carcinosis, a peritoneal pseudomyxoma or mesothelioma, or a primary carcinosis of the peritoneum regardless the number of prior treatment lines.
A PC and primary tumor considered to be resectable according to preoperative clinical and paraclinical data: absence of mesenteric retraction and absence of bladder invasion.
Patients in good general health (ASA ≤ 2).
Absence of cardiorespiratory failure (PaO2 > 60 mmHg in a stable condition, dyspnea ≤ NYHA stage 1, left ventricular ejection fraction > 60%.).
Prothrombin level >70 %, total bilirubin < 2 x the normal level, ASAT and ALAT < 2.5 x normal levels, and alkaline phosphatases < 5 x normal levels.
Creatinine clearance > 60 ml/min, polynuclear neutrophils > 1500/mm3, and a white blood cell count > 4000 /mm3.
Patients who give written, informed consent.
Patients affiliated with the French universal healthcare system.

Exclusion Criteria:

Patients with a PC with ovarian, mammary, biliary, pancreatic, or bronchial origin.
Evolutive patients after systemic chemotherapy.
Patients with a PC considered to be irresectable according to preoperative clinical and paraclinical data: mesenteric retraction or bladder invasion.
Patients in poor general health (ASA > 2).
Cardiorespiratory failure (dyspnea > NYHA stage 1, PaO2 < 60 mmHg in a stable condition)
Prothrombin level < 70 %.
Any brain abnormality showing on the head scan.
Signs of heart failure and especially left ventricular ejection fraction < 60% on the cardiac ultrasound.
Thrombocytopenia < 100 000 / mm3
Visceral metastases other than a single resectable liver metastasis.
Pregnancy or breast feeding.
Chronic inflammatory intestinal disease and/or an intestinal obstruction.
History of severe hypersensitivity to irinotecan hydrochloride trihydrate or one of the excipients of Campto.
Bilirubinemia > 3 times the normal upper limit
Yellow fever vaccine.
Prophylactic treatment with phenytoin.
Severe medullary insufficiency.

ID	Term
D065426	Cytoreduction Surgical Procedures
D000084262	Hyperthermic Intraperitoneal Chemotherapy

ID	Term
D013514	Surgical Procedures, Operative
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D006979	Hyperthermia, Induced