Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT01226550
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01226550
Study Brief:
Protocol Section:
NCT01226550