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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT02866903
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years old and ≤ 75 years old
* ECOG Performance Status (PS) 0-2
* Peritoneal carcinosis with locoregional extension or metastases of colorectal origin and uncertain resectability
* PCI \> 20 and / or infiltration of the hepatic pedicle and / or necessary digestive tract resections
* Systemic chemotherapy indication, compatible with the FOLFIRI + bevacizumab combination
* Satisfactory haematological evaluation: PNN rate greater than 1500 / mm3, platelet count greater than 100 G / l;
* Satisfactory renal and hepatic function : serum creatinine ≤1.5 times the normal lower values or creatinine clearance ≥50 ml / min, bilirubin ≤1.25 times lower normal values, AST / ALT ≤1.5 times the lower normal values (≤5 times the lower normal values for patients with liver metastases)
* No unstable conditions: myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer or any condition that could be aggravated by treatment or limit compliance (investigator assessment);
* No limitation in the number of previous treatments;
* Patients may have received conventional cytotoxic chemotherapy , hormonal or immunological targeted biological agents. They should have recovered from previous grade ≤2 toxicities
* Written informed consent
* Known RAS status.
Exclusion Criteria:
* Extraperitoneal metastases for which the site or number preclude potentially curative surgery at any moment during the course of the disease
* Sign of bowel obstruction or lesions whose topography indicates a risk of intestinal perforation or inflammatory bowel disease
* ECOG PS 3-4
* Contraindication to the placement of a intraperitoneal central line
* Contraindication specifically related to intraperitoneal administration of oxaliplatin
* known history of hypersensitivity to oxaliplatin or to the excipients
* peripheral sensory neuropathy grade ≥2
* Pregnant or lactating women
* Unable to give consent
* Patient under legal protection measures
* Refusal to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02866903
Study Brief:
Protocol Section:
NCT02866903