Status:
COMPLETED
Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Peritoneal Carcinosis (PC)
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomyci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01226550
Start Date
June 1 2007
End Date
April 1 2011
Last Update
December 19 2025
Active Locations (1)
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1
Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495