Clinical trial · Interventional
Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
NCT01226550CI-TRIAL-00099319completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinosis (PC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytoreductive surgery and HIPEC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cytoreductive surgery and HIPEC
- interventionNames
- Procedure: cytoreductive surgery and HIPEC
Primary outcomes (1)
- measure
- Morbidity rate
- timeFrame
- 30 days postoperative
- description
- postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)
Secondary outcomes (2)
- measure
- Mortality rate
- timeFrame
- 30 days postoperative
- measure
- Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTCotte E, Passot G, Tod M, Bakrin N, Gilly FN, Steghens A, Mohamed F, Glehen O. Closed abdomen hyperthermic intraperitoneal chemotherapy with irinotecan and mitomycin C: a phase I study. Ann Surg Oncol. 2011 Sep;18(9):2599-603. doi: 10.1245/s10434-011-1651-1. Epub 2011 Mar 19. PMID 21424369